[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-adenocarcinoma":648},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,76,0,25,[9,62,98,130,160,203,215,252,283,311,329,348,369,385,411,423,448,468,487,509,535,559,577,598,621],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100053405",false,"NCT05000294","Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types","Inclusion Criteria:\n\n* Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused or for whom there are no standard therapies that impart significant clinical benefit in the opinion of the treating investigator.\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal to 2 for phase 2.\n* Subjects must not have more than one malignancy at the time of enrollment\n* Adult subjects ≥ eighteen years of age\n* A clinical diagnosis consistent with stage IV \"immunogenically cold\" or otherwise incurable cancer of one of the following histologies: i) bile duct or gallbladder cancer ii) Metastatic breast cancer, HR-negative HER2-positive, who have received at least 3 lines of therapy for disease progression that includes: trastuzumab, pertuzumab\u002Ftrastuzumab, and ado-trastuzumab emtansine iii) neuroendocrine cancer with the following pathological characteristics: grade 2 or 3; well- or moderately- differentiated (Grades 1, 4, and poorly differentiated neuroendocrine pathologies are not eligible) iv) FIGO stage IV or metastatic (using 2021 FIGO classification) high grade serious or high grade endometrioid (based on local histopathological findings) ovarian cancer, primary peritoneal cancer and \u002F or fallopian-tube cancer that is platinum resistant, with no acceptable standard of care v) pancreatic adenocarcinoma vi) soft tissue sarcoma vii) prostate cancer subjects who are castrate-resistant (testosterone ≤ 50 ng\u002FdL) and have progressed on, declined, or are intolerant to other standard of care therapies. Subjects with prostate cancer must have failed at least one line of treatment with an androgen inhibitor (AI) (i.e. enzalutamide, abiraterone, etc.) or cytotoxic chemotherapy in the advanced or metastatic setting viii) vulvar cancer\n* Adequate hematologic and end-organ function\n* Subjects receiving therapeutic anticoagulation must be on a stable anticoagulant regimen for ≥ 2 weeks at start of protocol treatment\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative HIV test at screening with the following exceptions: subjects with a positive HIV test at screening are eligible only if they meet the following three conditions: 1) Are stable on anti-retroviral therapy 2) Have a CD4 count ≥ 200\u002FuL AND 3) Have an undetectable viral load.\n* Women of childbearing potential (WOCBP) must be using an adequate method of contraception (with a failure rate of \\\u003C1% per year) to avoid pregnancy throughout the study and for at least 160 days after the last dose of either study drug to minimize the risk of pregnancy.\n* Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 160 days following the last dose of study drug.\n* Measurable disease by RECIST criteria\n* A life expectancy of ≥ 12 weeks\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Must have formalin-fixed paraffin embedded (FFPE) tissue or 12 unstained slides available for research purposes. Tissue must have been obtained within the last 3 years.\n* If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a tumor site that is not the only site of measurable disease\n* Subject must be able to swallow capsules\n\nExclusion Criteria:\n\n* Subjects with known MSI-H or dMMR tumor status\n* Subjects with severe uncontrolled hypertension as defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg\n* Subjects who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 160 days after the last dose of study drug\n* Females who are pregnant or breastfeeding\n* History of leptomeningeal disease\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently, except in the case of ovarian cancer with ascites, which may require more frequent drainage). Subjects with indwelling catheters are allowed.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  1. subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n     * Rash must cover \\\u003C10% of body surface area\n     * Disease is well controlled at baseline and requires only lowpotency topical corticosteroids\n     * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy other than the malignancies listed in the inclusion criteria of enrollment within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Current treatment with anti-viral therapy for hepatitis B virus (HBV)\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  1. Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  2. Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment, during treatment with atezolizumab, and for 160 days after the last dose of atezolizumab. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Subjects may receive non-live COVID-19 vaccine.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with Tumor Mutation Burden (TMB) ≥10\n* Treatment with any cancer directed therapy (i.e. chemotherapy, radiation therapy, Y90, microwave ablation, immunotherapy, etc.) within 28 days of study start\n* Subjects with treated brain metastases that have remained stable for at least 90 days without steroids are allowed. Subjects with signs of symptoms or history of brain metastasis must have a CT or MRI of the brain within 30 days prior to the start of protocol therapy.\n* Subjects with autoimmune diseases requiring current treatment and subjects with history of severe autoimmune diseases, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency who are stable on therapy are allowed.\n* Inability to discontinue use of medications contraindicated by the study treatment\n* Proteinuria \\> 2.5 g\u002F24 hours or 3+ with urine dipstick\n* QTc interval \\> 470 at screening or known cardiovascular disease defined as (a) a clinically significant abnormal ECG at screening, or (b) myocardial infarction within 12 weeks prior to start of protocol therapy","ALL","18 Years","99 Years",{"count":19,"type":20},29,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies.\n\nDespite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically \"cold\" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer.\n\nVascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer.\n\nThrough the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.",[27,28,29,30,31,32,33,34,35],"Bile Duct Cancer","Gall Bladder Cancer","Breast Cancer","Neuroendocrine Tumors","Ovarian Cancer","Pancreatic Adenocarcinoma","Soft Tissue Sarcoma","Vulvar Cancer","Prostate Cancer",[37,38,39,40,41,42,43,44,45,46,47,48],"immunologically cold tumors","breast cancer","bile duct cancer","gallbladder cancer","neuroendocrine cancer","ovarian cancer","pancreatic adenocarcinoma","soft tissue sarcoma","prostate cancer","vulvar cancer","TKI","checkpoint inhibitor","RECRUITING","2026-07-10",{"date":52,"type":53},"2026-07-13","ACTUAL",{"date":55,"type":53},"2021-12-07",{"date":57,"type":20},"2027-06",{"name":59,"class":60},"University of Florida","OTHER",1,{"id":63,"slug":4,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":71,"conditions":72,"keywords":78,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100054097","NCT05877599","A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicentre Platform Study to Evaluate the Safety and Preliminary Anti-tumour Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Participants With Advanced Malignancies That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria (Module 1)\n\n* Subjects must be at least 18 years of age\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria (Module 1)\n\n* Any another primary malignancy within the 3 years prior to enrollment\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.\n\nKey Inclusion Criteria (Module 2 - hematological malignancies)\n\n* At least 18 years of age\n* Diagnosis of AML or MDS that allows for efficacy assessments\n* Confirmation of TP53 R175H variant mutation in cancer cells\n* Subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* ECOG performance status of 0 to 1\n\nKey Exclusion Criteria (Module 2 - hematological malignancy)\n\n* Acute promyelocytic leukaemia or isolated extramedullary disease\n* Another primary malignancy within 2 years (with exceptions)\n* HSCT within 100 days or immunosuppression for GvHD within 4 weeks\n* History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells\n* Prior stroke, ischemic attack, significant cardiac disease, heart failure\n* Prior adoptive modified cell therapy\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.",{"count":69,"type":20},45,[23],"Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies",[73,74,75,32,29,76,31,77],"Non-small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Carcinoma","Other Solid Tumors","Myeloid Neoplasms (AML\u002FMDS)",[79,80,81,82,83,84,85,29,31,86,87,88],"Cell therapy","TP53","Solid tumors","Non-small cell lung cancer","Head and neck squamous cell carcinoma","Colorectal carcinoma","Pancreatic adenocarcinoma","AML","MDS","TCR",{"date":52,"type":53},{"date":91,"type":53},"2023-07-12",{"date":93,"type":20},"2029-07-31",{"name":95,"class":96},"AstraZeneca","INDUSTRY",18,{"id":99,"slug":4,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100053828","NCT07670312","Evaluation of XYA02 in Patients With Advanced Solid Tumors","A Phase 1b\u002F2, Multicenter, Non-randomized, Open-label, Multiple Dose First- In-Human Study of XYA02 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Signed informed consent form(s) (ICFs) obtained at Screening.\n2. Has an eligible relapsed\u002Frefractory tumor with measurable disease based on RECIST 1.1 at Screening.\n3. Age ≥18 years at Screening and confirmed at the discretion of the Investigator.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at Screening.\n5. Platelet (PLT) count ≥100,000\u002FmcL at Screening.\n6. Hemoglobin ≥9.5 g\u002FdL without packed red blood cells (RBCs) transfusion within 14 days prior to Screening.\n7. Absolute neutrophil count (ANC) ≥1,500\u002FmcL at Screening.\n8. Estimated creatinine clearance (CrCl) \\>60 mL\u002Fmin at Screening. Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤3 × the upper limit of normal (ULN) at Screening.\n\n10\\. Total bilirubin ≤1.5 × ULN at Screening; in patients with a documented history of Gilbert syndrome ≤3 × ULN.\n\n11\\. At least 28 days from treatment with monoclonal antibody-based therapies at Screening.\n\n12\\. At least 5 half-lives from treatment with chemotherapy and small molecule inhibitors at Screening. 13. At least 28 days from experimental therapies not covered above at Screening.\n\n14\\. At least 28 days from radiation to more than 30% of the bone marrow or a wide field of radiation at Screening. Radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study drug is acceptable. (In case of patients treated with radiotherapy, previously irradiated lesions should not be considered a target lesion on computed tomography \\[CT\\] unless evidence of regrowth\u002Fdisease progression has been documented.) 15. At least 28 days from major surgery or significant trauma with recovery of AEs to NCI-CTCAE Grade 1 or baseline at Screening.\n\n16\\. Availability of archival tissue or, if unavailable, will be willing to undergo a tumor biopsy if a low-risk biopsy procedure is feasible at Screening. 17. Has a life expectancy of ≥ 3 months at Screening.\n\nAdditional Inclusion Criteria for Phase 1 (Dose Escalation and Backfill):\n\n18\\. Has pathologically documented advanced, relapsed, or refractory NSCLC (non-squamous), ovarian (high grade serous), gastric\u002Fesophageal\u002FGEJ adenocarcinoma, or CRC at Screening. 19. Patient must have progressed on, have relapsed after, be refractory to, or be intolerant of at least 1 prior systemic therapy, without available subsequent standard of care and have no satisfactory alternative treatment options. No more than 4 prior lines of systemic therapy for advanced, relapsed, or refractory disease in NSCLC and ovarian and no more than 3 prior lines of systemic therapy in gastric\u002Fesophageal\u002FGEJ adenocarcinoma or CRC (excluding adjuvant chemotherapy).\n\nAdditional Inclusion Criteria for Phase 2 (Dose Expansion):\n\n20\\. Cohorts for 5 different prioritized tumor types and 1 basket cohort that are advanced\u002Funresectable or metastatic at Screening according to the following criteria:\n\n1. Cohort 2A: NSCLC non-squamous. Histologically confirmed locally advanced or metastatic NSCLC (non-squamous) that have relapsed after or are refractory to platinum-doublet based chemotherapy and\u002For immune checkpoint inhibitor (in combination or sequential). Patients with EGFR or anaplastic lymphoma kinase (ALK) mutations should have been treated with appropriate targeted therapy. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy and\u002For immunotherapy).\n2. Cohort 2B: Ovarian. Histologically confirmed advanced or metastatic high-grade serous ovarian cancer that have relapsed after or are refractory to at least 1 prior line of chemotherapy and have no other satisfactory treatment options. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy or maintenance regimen).\n3. Cohort 2C: Gastric\u002Fesophageal\u002FGEJ adenocarcinoma. Histologically confirmed advanced or metastatic gastric, esophageal or GEJ adenocarcinoma that have relapsed after or are refractory to at least 1 prior line of therapy. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n4. Cohort 2D: CRC. Histologically confirmed advanced or metastatic CRC that have relapsed after or are refractory to at least 1 prior line of therapy. BRAF mutated patients are excluded. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n5. Cohort 2E: Pancreatic cancer. Histologically confirmed locally advanced or metastatic pancreatic cancer that have relapsed after or are refractory to at least 1 prior systemic treatment regimen. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n6. Cohort 2F: Tumor agnostic. Histologically confirmed advanced or metastatic solid tumors other than ones in Cohorts 2A to 2E that have relapsed after treatment without available subsequent standard of care. The tumor indications in this group will be selected based on data from phase 1 and preclinical data.\n\nExclusion Criteria:\n\n1. Has been refractory (did not have a tumor response) to previous treatment with a topoisomerase 1 (TOP1) inhibitor antibody-drug conjugate, at the discretion of the investigator.\n2. Has a medical history of symptomatic congestive heart failure (CHF; New York Heart Association \\[NYHA\\] classes II-IV), prior documented left ventricular ejection fraction (LVEF) \\\u003C 50%, or serious cardiac arrhythmia requiring treatment at Screening and at the discretion of the Investigator.\n3. Has a clinically significant medical history of myocardial infarction or unstable angina within 6 months before Screening at the discretion of the Investigator.\n4. Has a QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 millisecond (ms) in males and \\> 470 ms in females based on a 12-lead electrocardiogram (ECG) in triplicate performed at Screening.\n5. Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at Screening at the discretion of the Investigator.\n6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals at Screening at the discretion of the Investigator.\n7. Known history of human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at Screening. If known history of hepatitis, active hepatitis B infection is defined as hepatitis B surface antigen (HbsAg) positive or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive; and active hepatitis C infection is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) positive.\n8. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days before Screening.\n9. Male and female patients who are unwilling to use contraceptive methods at Screening (eg, concomitant use of a spermicidal agent and barrier contraceptive, intrauterine contraceptive during the study and for at least 7 months after the last dose of XYA02).\n10. Has clinically active brain metastases, defined as untreated and symptomatic, or requires therapy with steroids or anticonvulsants to control associated symptoms at Screening and at the discretion of the Investigator. Note: Patients with untreated asymptomatic brain metastases may be included in the study if they do not require radiotherapy treatment or surgical treatment, do not require treatment with steroids, and there are no untreated brain lesions \\> 20 mm in size.\n11. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, lymphopenia) not yet resolved to NCI-CTCAE Grade ≤ 1 or baseline at Screening. Patients with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator (eg, peripheral neuropathy, endocrinopathies).\n12. Has a concomitant medical condition that would increase the risk of toxicity at Screening.\n13. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product at Screening.\n14. Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer at Screening.",{"count":105,"type":20},190,[23,24],"This study will evaluate the safety, tolerability, and efficacy of XYA02 in participants with advanced solid tumors.",[109,110,31,111,112,32],"MUC1-expressing Advanced, Relapsed and\u002For Refractory Solid Tumors","Non-Small Cell Lung Cancer","GEJ Adenocarcinoma","Colorectal Cancer",[114,115,110,116,117,118,119],"MUC-1","solid tumor","Ovarian","GEJ adenocarcinoma","Colorectal","Pancreatic","NOT_YET_RECRUITING","2026-07-09",{"date":52,"type":53},{"date":124,"type":20},"2026-07-15",{"date":126,"type":20},"2030-07-15",{"name":128,"class":96},"XYone Therapeutics, Inc",5,{"id":131,"slug":4,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":157,"locationsCount":159},"100630515","NCT07488676","A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors","A Phase 1b\u002F2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types","Inclusion Criteria:\n\n* Participant has a histologically confirmed diagnosis of gastroesophageal (gastric\u002FGEJ\u002Fesophageal) adenocarcinoma, pancreatic adenocarcinoma, or pan-tumor (cholangiocarcinoma, colorectal adenocarcinoma, NSCLC \\[adenocarcinoma\\], SCLC, ovarian mucinous carcinoma or invasive breast cancer \\[ER\u002FPR+HER2-; ER\u002FPR-HER2+; ER\u002FPR+HER2+ (triple positive); ER\u002FPR-HER2- (triple negative)\\].\n* Participant has radiologically confirmed uLA\u002Fm gastroesophageal (gastric\u002FGEJ\u002Fesophageal) adenocarcinoma, pancreatic adenocarcinoma or pan-tumor within 28 days prior to the first dose of study intervention.\n* Cohorts 1 to 3 only: Participant has measurable disease according to RECIST v1.1 within 28 days prior to the first dose of study intervention. For participants with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.\n* Cohort 4 only: Participant has radiologically evaluable disease (measurable and\u002For non-measurable) according to RECIST v1.1, within 28 days prior to the first dose of study intervention. For participants with only 1 evaluable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.\n* Participant's tumor expresses CLDN18.2.\n* Participant has received at least 1 line of therapy for uLA\u002Fm disease.\n* Participant has an ECOG performance status of 0 or 1.\n* Participant has a predicted life expectancy \\>= 12 weeks.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a women of childbearing potential (WOCBP)\n  * WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 5 half-lives (45 days) plus 6 months after final investigational study intervention administration.\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (45 days) plus 6 months after final investigational study intervention administration.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 5 half-lives (45 days) plus 6 months after final investigational study intervention administration.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 5 half-lives (45 days) plus 3 months after final investigational study intervention administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 5 half-lives (45 days) plus 3 months after final investigational study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 5 half-lives (45 days) plus 3 months after final investigational study intervention administration.\n* Participant must meet all of the criteria based on the locally analyzed laboratory tests collected within 14 days prior to the first dose of study intervention. In case of multiple local laboratory tests within this period, the most recent data should be used.\n* Participant is willing to provide or has sufficient tumor tissue for central biomarker assessment.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study.\n\nExclusion Criteria:\n\n* Cohorts 1, 2 and 3 only: Participant's disease is of the non-adenocarcinoma histology or mixed histology containing adenocarcinoma.\n* Cohorts 1, 2 and 3 only: Participant has received \\> 2 prior lines of therapy for uLA\u002Fm disease.\n\n  * Participants in Cohort 4 (pan-tumor) may enroll regardless of the number of prior lines of therapy, if they are not eligible for, decline, or do not have any available standard of care treatment options.\n* Participant has complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.\n* Participant has significant gastric bleeding or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to the first dose of study intervention and\u002For an untreated peptic ulcer disease that would preclude the participant from participation.\n* Participant has significant bleeding disorders or has had vasculitis within 3 months prior to the first dose of study intervention.\n* Participant has a history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose of study intervention.\n* Participant has symptomatic, untreated brain metastases or meningeal carcinomatosis (carcinomatous meningitis) from the primary malignancy. A participant with stable central nervous system metastases for \\> 3 months without need of steroids for \\>= 2 weeks prior to the first dose of study intervention is eligible.\n* Participant has a past or current mental illness that is difficult to control.\n* Participant has unresolved pneumonitis or a history of non-infectious pneumonitis such as immune-related pneumonitis or radiation-induced pneumonitis for which the participant is taking glucocorticoids or needed glucocorticoids within 6 months prior to the first dose of study intervention.\n* Participant has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\]) or hepatitis C infection. Screening for these infections should be conducted if indicated per local requirements.\n\n  * If participant is negative for HBsAg, but hepatitis B core antibody (HBcAb) and\u002For hepatitis B surface antibody (HBsAb) positive, a hepatitis B DNA test will be performed; if the test is positive, the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results, is eligible.\n  * Participant treated for HCV with undetectable viral load results is eligible.\n* Participant has an active infection requiring systemic therapy that has not completely resolved within 7 days prior to the first dose of study intervention.\n* Participant has a malignancy for which treatment is required, has a history of another malignancy within the past 5 years, except malignancies for which participant received curative therapy without recurrence for the last 5 years (e.g., adequately resected non-melanoma skin cancer, localized prostate cancer), or had treatment for carcinoma in situ.\n* Participant has clinically significant third spacing (large amount of pleural fluid or ascites) that requires frequent percutaneous draining or requires placement of a drainage catheter for adequate control.\n* Participant has any AE from prior antitumor treatments that has not yet recovered to grade 0 or 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0 (except alopecia).\n* Participant has an active autoimmune disease or other medical condition that has required high dose systemic steroids at the time of screening.\n* Participant has known peripheral neuropathy \\> grade 1 (except when the sole neurological abnormality is absence of deep tendon reflexes).\n* Participant has sinusoidal obstruction syndrome, formerly known as veno-occlusive disease; if present, should be stable or improving.\n* Participant has significant cardiovascular disease, including any of the following:\n\n  * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to the first dose of study intervention.\n  * History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes), cardiac arrhythmias requiring anti-arrhythmic medications (a participant with rate controlled atrial fibrillation for \\> 1 month prior to the first dose of study intervention is eligible) or obligate use of cardiac pacemaker.\n  * QTc interval \\> 470 msec\n  * Documented history or family history of congenital long QT syndrome.\n* Participant has ongoing or previous interstitial lung disease, active diverticulitis or solid organ or stem cell transplant.\n* Participant has a serious non-healing wound or bone fracture within 28 days prior to study intervention.\n* Participant has had a major surgical procedure within 28 days prior to the first dose of study intervention and has not completely recovered from the surgical procedure \\\u003C= 14 days prior to the first dose of study intervention.\n* Participant has received chemotherapy, immunotherapy or investigational therapy \\\u003C= 14 days prior to the first dose of study intervention and has not recovered from any related toxicity. Palliative radiotherapy is allowed and must be completed \\> 14 days prior to the first dose of study intervention.\n* Participant has received prior CLDN18.2 ADC. Prior treatment with CLDN18.2 monoclonal antibody or bi-specific T-cell engager is allowed.\n* Participant has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.\n* Participant has a known or suspected hypersensitivity to ASP546C or any components of the formulation used.\n* Participant has a clinically significant disease or comorbidity that in the opinion of the investigator may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Cohorts 1 and 2 (gastroesophageal adenocarcinoma) only: Participant has known HER2 positive status defined as immunohistochemistry (IHC) 3+ or IHC 2+\u002F in situ hybridization (ISH) +. ISH positive is defined as HER2\u002F chromosome enumeration probe 17 (CEP17) ratio ≥ 2.0 or an average HER2 copy number ≥ 6.0 signals\u002Fcell.",{"count":137,"type":20},150,[23,24],"This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors. GEJ is where the food pipe (esophagus) joins the stomach.\n\nThis study is in 2 parts. In both parts of the study, ASP546C will be given once in 3-week cycles. It will be given slowly through a tube into a vein. This is called an infusion.\n\nIn Part 1, people with gastric cancer or GEJ cancer can take part. They will receive an infusion of either a higher dose or a lower dose of ASP546C.\n\nIn Part 2, people with pancreatic cancer or who have one of the other solid tumors can take part. Part 2 doesn't include people with gastric cancer or GEJ cancer. All people in this part of the study will receive an infusion of the higher dose of ASP546C.\n\nPeople will visit the clinic on certain days to receive ASP546C and have health checks. The number of visits and checks done during the study will depend on the health of each person and whether they are still receiving infusions of ASP546C.",[141,32],"Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma",[141,32,143,144,145,146,147,148,149,150],"Cholangiocarcinoma","Colorectal adenocarcinoma","Non-small cell lung cancer (NSCLC) (adenocarcinoma)","Small cell lung cancer (SCLC)","Ovarian mucinous carcinoma","Invasive breast cancer","ASP546C","Claudin 18.2","2026-07-01",{"date":153,"type":53},"2026-07-02",{"date":155,"type":53},"2026-05-04",{"date":93,"type":20},{"name":158,"class":96},"Astellas Pharma Global Development, Inc.",14,{"id":161,"slug":4,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":181,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100431255","NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":167,"type":20},1109,[23,24],"The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[171,172,173,174,175,176,177,32,178,179,180],"Cervical Cancer","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Non-Small-Cell Lung Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Urothelial Carcinoma","Melanoma","Ovarian Neoplasms","Triple Negative Breast Neoplasms",[182,171,183,184,185,172,186,173,187,188,174,189,190,175,176,177,32,178,179,180,191,192],"BMS-986340","CRC","First-in-human","GEJ","HNSCC","MSS CRC","Nivolumab","NSCLC","SCCHN","Docetaxel","Pumitamig","2026-06-29",{"date":195,"type":53},"2026-06-30",{"date":197,"type":53},"2021-05-27",{"date":199,"type":20},"2031-08-31",{"name":201,"class":96},"Bristol-Myers Squibb",47,{"id":204,"slug":4,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":107,"conditions":207,"keywords":208,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":213,"leadSponsor":214,"locationsCount":129},"100644475",{"count":105,"type":20},[23,24],[109,110,31,111,112,32],[114,115,110,116,117,118,119],"2026-06-25",{"date":211,"type":53},"2026-06-26",{"date":124,"type":20},{"date":126,"type":20},{"name":128,"class":96},{"id":216,"slug":4,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":226,"conditions":227,"keywords":235,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":251},"100630728","NCT07491445","Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma","RASolute 303","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.\n* Documented RAS mutation status, either mutant or wild-type.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.\n* Active or known history of untreated central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":223,"type":20},900,[225],"PHASE3","The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.",[228,229,230,231,232,233,32,234],"Pancreatic Cancer","Pancreatic Cancer Metastatic","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Adenocarcinoma Metastatic","Pancreatic Adenosquamous Carcinoma",[228,230,236,237,238,239,240,241,242,229,233,234,32],"Pancreatic Ductal Adenocarcinoma","RAS","KRAS","NRAS","HRAS","RAS Wild-Type","RAS Mutation","2026-06-24",{"date":209,"type":53},{"date":246,"type":53},"2026-03-09",{"date":248,"type":20},"2029-03",{"name":250,"class":96},"Revolution Medicines, Inc.",13,{"id":253,"slug":4,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100636166","NCT07562152","Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)","MAPKeeper 301","Inclusion Criteria:\n\n* Must be ≥18 years of age\n* Must have confirmed diagnosis according to AJCC staging as follows:\n\n  * Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participants must be treatment naive as follows:\n\n  * First-line PDAC participants will have received no previous systemic anti-cancer therapy\n* Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria\n* Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values\n\nExclusion Criteria:\n\n* Inability to swallow oral medications\n* Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma\n* Participants with only locally advanced disease\n* Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases",{"count":260,"type":20},510,[225],"The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.",[228,229,230,231,236,233,232,32],[265,266,267,268,269,270,271,272],"mitogen-activated protein kinase (MAPK)","MAPK","MEK","metastatic cancer","gemcitabine","nab-paclitaxel","nab-p","atebimetinib","2026-06-18",{"date":275,"type":53},"2026-06-22",{"date":277,"type":20},"2026-06",{"date":279,"type":20},"2029-02",{"name":281,"class":96},"Immuneering Corporation",19,{"id":284,"slug":4,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":292,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":310},"100569762","NCT06698458","Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer","A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and\u002For cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).\n* Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion\n* Target lesion is technically amenable for Alpha DaRT sources implantation.\n* Measurable lesion per RECIST (version 1.1) criteria\n* Lesion size ≤ 5 cm in the longest diameter\n* Interstitial radiation indication validated by a multidisciplinary team.\n* ECOG Performance Status Scale 0 -2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fμl, granulocyte ≥ 1500\u002Fμl\n* Platelet count ≥60,000\u002Fμl\n* Creatinine ≤1.9 mg\u002FdL\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Age ≥18 years old\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.\n\nExclusion Criteria:\n\n* For Cohort 1 only: Borderline unresectable pancreatic cancer, and\u002For fit for surgical exploration unless patient refuses surgery.\n* For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment.\n\nExceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.\n\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after DaRT insertion\n* Patients who are at high risk of complications from radiation due to genetic conditions\u002Fmutations, inflammatory bowel disease, or connective tissue disease.","120 Years",{"count":291,"type":20},40,[293],"NA","This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to:\n\n* Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival.\n* Assess pain control\n* Assess rate of surgical resection in Cohort 1.",[228,32,296],"Metastatic Pancreatic Cancer",[298,299,32,300],"Alpha radiation","pancreatic cancer","Unresectable Pancreatic Cancer","2026-06-15",{"date":303,"type":53},"2026-06-16",{"date":305,"type":53},"2025-06-17",{"date":307,"type":20},"2026-12",{"name":309,"class":96},"Alpha Tau Medical LTD.",15,{"id":312,"slug":4,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":289,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":61},"100518161","NCT06026943","Alpha Radiation Emitters for the Treatment of Pancreatic Cancer for the Treatment of Locally Advanced Pancreatic Cancer","A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven NCCN locally advanced PC\n* Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient does not wish to go through surgery.\n* DaRT indication validated by a multidisciplinary team.\n* Measurable lesion per RECIST (version 1.1) criteria\n* TC at Verona's center (not been over a month)\n* Lesion size ≤ 5 cm in the longest diameter\n* Age ≥18 years old\n* ECOG Performance Status Scale ≤ 2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fμl, granulocyte ≥ 1500\u002Fμl\n* Platelet count ≥60,000\u002Fμl\n* Calculated or measured creatinine clearance ≥ 30cc\u002Fmin. Calculated or measured creatinine clearance can be ≥ 40cc\u002Fmin given stability of creatinine levels over the past three weeks (at least 1 test per week).\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n\nExclusion Criteria:\n\n* Concomitant chemotherapy or immunotherapy within the past 4 weeks\n* Prior radiation therapy to the pancreas\n* CA 19-9 \\> 1000 Units\u002Fml\n* Fit for surgical exploration unless the patient refuses surgery\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy (not including cholangitis) or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.",{"count":310,"type":20},[293],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer",[228,300,32],[299,300,32,298,322],"Pancreas Cancer",{"date":303,"type":53},{"date":325,"type":53},"2026-05-06",{"date":327,"type":20},"2028-01",{"name":309,"class":96},{"id":330,"slug":4,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":21,"phases":336,"briefSummary":319,"conditions":337,"keywords":338,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100489793","NCT05657743","Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer (Feasibility and Safety)","A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Advanced Pancreatic Cancer","Inclusion Criteria\n\n* Histologically and\u002For cytologically proven locally advanced or metastatic pancreatic adenocarcinoma\n* Patients must have i) received at least one line of chemotherapy OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery or the patient does not wish to go through surgery\n* Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician\n* Interstitial radiation indication validated by a multidisciplinary team\n* Measurable lesion per RECIST (version 1.1) criteria\n* Lesion size ≤ 5 cm in the longest diameter\n* Age ≥18 years old\n* ECOG Performance Status Scale ≤ 2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n* Platelet count ≥60,000\u002Fµl\n* Calculated or measured creatinine clearance ≥ 60cc\u002Fmin. Calculated or measured creatinine clearance can be≥ 40cc\u002Fmin given stability of creatinine levels over the past three weeks (at least 1 test per week).\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n\nExclusion Criteria:\n\n* Concomitant chemotherapy or immunotherapy within the past 4 weeks\n* Brain metastases\n* Borderline unresectable pancreatic cancer, and\u002For cases fit for surgical exploration unless patient refuses surgery\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.",{"count":310,"type":20},[293],[228,300,296,32],[299,300,296,32,339,298,340],"Pancreas Neoplasm","Pancreas Metastases",{"date":303,"type":53},{"date":343,"type":53},"2023-08-16",{"date":345,"type":20},"2027-11",{"name":309,"class":96},2,{"id":349,"slug":4,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":21,"phases":357,"briefSummary":358,"conditions":359,"keywords":360,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":368},"100641682","NCT07621718","Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )","RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma","RASolute 305","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Diagnosis of metastatic disease ≤ 6 weeks prior to screening.\n* Documented KRAS G12D mutation status.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.\n* Prior systemic RAS-targeted therapy any time prior to randomization.\n* Presence of other known driver mutations with approved targeted therapies\n* Active or known history of untreated central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":356,"type":20},670,[225],"The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.",[228,229,230,231,232,233,32,234],[228,230,236,237,238,242,229,233,234,32],"2026-06-12",{"date":303,"type":53},{"date":364,"type":53},"2026-05-22",{"date":366,"type":20},"2030-04-22",{"name":250,"class":96},3,{"id":370,"slug":4,"hasResults":11,"nctId":64,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":21,"phases":375,"briefSummary":376,"conditions":377,"keywords":378,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":384,"locationsCount":97},"100506685","A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Subjects With Unresectable, Advanced and\u002For Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria\n\n* Subjects must be at least 18 years of age, at the time of signing the informed consent.\n* Subjects must be capable of giving signed informed consent.\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele) as confirmed by an CLIA-accredited laboratory-based test.\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion per computed tomography (CT) scan or magnetic resonance imaging (MRI) per RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n* Per Investigator judgement, subject is likely to complete study visits and\u002For procedures per the protocol and comply with study requirements for study participation\n\nKey Exclusion Criteria\n\n* Any another primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or rIL-2; or known sensitivity or allergy to methotrexate, gentamicin, or other aminoglycosides.\n* Any form of primary immunodeficiency.\n* Live vaccine ≤ 4 weeks prior to enrollment or plans to have a live vaccine prior to planned lymphodepleting chemotherapy and\u002For NT-175 treatment.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.",{"count":69,"type":20},[23],"Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.",[73,74,75,32,29,76,31],[79,80,81,82,83,84,85,29,31,88],"2026-06-09",{"date":381,"type":53},"2026-06-10",{"date":91,"type":53},{"date":93,"type":20},{"name":95,"class":96},{"id":386,"slug":4,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":393,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},"100467347","NCT05365581","A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer","A Phase 1\u002F1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression","Inclusion Criteria (IC):\n\n* Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF).\n* Female participant is not pregnant, confirmed by serum pregnancy test \\&vmedical evaluation by interview \\& at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration.\n* Female participant must agree not to breastfeed starting at screening \\& throughout the study period \\& for 6 months after the final study intervention administration.\n* Female participant must not donate ova starting at screening \\& throughout the study period \\& for 6 months after the final study intervention administration.\n* Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period \\& for 6 months after the final study intervention administration.\n* Male participant must not donate sperm during the treatment period \\& for 6 months after the final study intervention administration.\n* Male participant with pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period \\& for 6 months after the final study intervention administration.\n* Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing.\n* Participant has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study intervention.\n* Participant has at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study intervention. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant has QT interval by Fredericia (QTcF) =\\\u003C 470 msec.\n* Participant agrees not to participate in another interventional study while receiving study Intervention in the present study.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant has predicted life expectancy \\>= 12 weeks.\n* Participant must meet all of criteria based on laboratory tests within 7 days prior to the first dose of study Intervention. In case of multiple laboratory data within this period, the most recent data should be used. If a participant has received a recent blood transfusion, the laboratory tests must be obtained \\>= 1 week after any blood transfusion.\n\nMonotherapy Disease specific Criteria (MDSC): Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed metastatic, locally advanced unresectable gastric\u002Fgastroesophageal junction (GEJ) adenocarcinoma.\n* Escalation: Participant with gastric\u002FGEJ adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).\n\n  * Unique to South Korea: Participant with gastric\u002FGEJ adenocarcinoma who has refused standard approved therapies is not allowed.\n* Expansion: Participant with gastric\u002FGEJ adenocarcinoma must have received no more than 3 prior lines of systemic chemotherapy treatment.\n\n  * Unique to EU: Expansion: Participant with gastric\u002FGEJ adenocarcinoma must have received at least first-line standard therapies in the metastatic setting, must have received ramucirumab treatment if eligible \\& where ramucirumab is available, \\& no more than 3 prior lines of systemic chemotherapy treatment.\n\nMDSC: Pancreatic Cancer\n\n* Participant has histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.\n* Escalation: Participant with pancreatic adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).\n\n  * Unique to South Korea: Participant with pancreatic adenocarcinoma who has refused standard approved therapies is not allowed.\n* Expansion: Participants with pancreatic adenocarcinoma must have received no more than 2 prior lines of systemic chemotherapy treatment.\n\nNote: Participants with locally advanced unresectable pancreatic adenocarcinoma will not be admitted in monotherapy arms.\n\n* Unique to EU: Participant with pancreatic adenocarcinoma must have received at least first-line standard therapies in the metastatic setting \\& no more than 2 prior lines of systemic chemotherapy treatment.\n\nFor all participants in combination therapy (CT) administration:\n\n* If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n\nCombination Therapy Disease-specific (CTDS) IC: ASP2138 in Combination with Pembrolizumab \\& mFOLFOX6 as First-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma has progressed \\& must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.\n* Participant has a human epidermal growth factor receptor 2 (HER2)-negative tumor per local testing.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\n(Unique to South Korea: For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 15 months after final study intervention for women \\& 12 months after final study intervention for men).\n\nUnique to EU:\n\n* Participant must have a PD-L1 CPS ≥ 1.\n\nCTDS IC: ASP2138 in Combination with Ramucirumab \\& Paclitaxel as Second-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma must have previously received 1 line of systemic chemotherapy treatment (i.e., documented objective radiological or clinical disease progression after first line platinum \\& fluoropyrimidine treatment in the metastatic setting or disease progression during or within 4 months of the last dose of perioperative treatment.\n* For combination therapy with paclitaxel, female participant must follow contraception guidelines from time of informed consent through at least 7 months after final study intervention.\n\nCTDS IC: ASP2138 in Combination with mFOLFIRINOX as First-line Therapy in Pancreatic Cancer\n\n* Participant has histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.\n* Participant has confirmed metastatic or locally advanced unresectable pancreatic adenocarcinoma.\n* Participant has pancreatic adenocarcinoma, has progressed \\& must not have received prior systemic anticancer therapy for their advanced disease. However, participants may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as they were completed at least 6 months prior to enrollment and without disease progression or recurrence.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\n(Unique to South Korea: For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 15 months after final study intervention for women \\& 12 months after final study intervention for men).\n\nJapan \\& Korea Specific:\n\nFor All Participants in ASP2138 in Combination with Pembrolizumab \\& CAPOX:\n\n\\- If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n\nCTDS IC: ASP2138 in Combination with Pembrolizumab \\& CAPOX as First-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.\n* Participants have a HER2-negative tumor per local testing.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\nExclusion Criteria (EC):\n\n* Participant has received other investigational agents, or antineoplastic therapy including other immunotherapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of study intervention administration.\n* Participant has any condition which makes the participant unsuitable for study participation.\n* Participant has known immediate or delayed hypersensitivity or contraindication to any component of study intervention.\n* Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or chimeric antibodies.\n* Participant weighs \\\u003C 40 kg.\n* Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study intervention. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast use are allowed.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Participant has significant gastric bleeding \\&\u002For untreated gastric ulcers that exclude the participant from participation.\n* Participant has symptomatic CNS metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable \\& have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention \\& are not requiring immunosuppressive doses of systemic steroids (\\> 10 mg per day of prednisone or equivalent) for longer than 2 weeks.\n* Participant is known to have HIV infection. However, participants with cluster of differentiation (CD4) + T cell counts \\>= 350 cells\u002FµL \\& no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements.\n\n  * For participant who is negative for HBsAg, but hepatitis B core antibody (HBc Ab) positive, a hepatitis B virus deoxyribonucleic acid test will be performed \\& if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test results are eligible.\n  * Participant treated for HCV with undetectable viral load results are eligible\n* Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.\n* Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.\n* Participant has a clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has psychiatric illness or social situations that would preclude study compliance.\n* Participant has had a major surgical procedure 28 days before start of study intervention \\& has not fully recovered.\n* Participant has received radiotherapy metastatic or for locally advanced unresectable gastric\u002FGEJ or metastatic pancreatic adenocarcinoma 14 days prior to start of study intervention \\& has NOT recovered from any related toxicity.\n* Participant has another malignancy for which treatment is required.\n* Participant who has received CLDN18.2-targeted therapy (e.g., zolbetuximab or chimeric antigen receptor CLDN18.2-specific T cells) prior to first dose of study intervention administration is not eligible for dose escalation cohorts. However, a participant who has received CLDN18.2-targeted therapy greater than 28 days or 5 half-lives (whichever is longer) prior to first dose study intervention administration is eligible for dose expansion cohorts only, with the exception of participants who have experienced Grade \\>= 3 gastrointestinal toxicity after receiving an CLDN18.2-targeted therapy.\n* Participant has a history or complication of interstitial lung disease.\n\nChina Specific:\n\nParticipant who has received treatment with herbal medications that have known antitumor activity within 28 days prior to first dose of study treatment.\n\nFor all participants in CT administration:\n\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab \\& mFOLFOX6 \\[all components\\], ramucirumab \\& paclitaxel or mFOLFIRINOX \\[all components\\]).\n* For 5 FU (fluorouracil): Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded; however, participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast or for chemotherapy (as part of CT administration) are allowed.\n* Participant is known to have HIV infection.\n* NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells\u002FµL \\& no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.\n* Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention (Unique to EU: high blood pressure Stage 2 is defined as ≥ 140\u002F90 mmHg).\n* Participant has a history of ascites requiring drainage more than twice in the past 7 days.\n\nCTDS EC: ASP2138 in Combination with Pembrolizumab \\& mFOLFOX6 as First-line Therapy in Gastric\u002FGEJ Cancer:\n\n* Participant has history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant received live-virus vaccination within 30 days prior to the first dose of study intervention.\n* Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients that require replacement therapy (e.g., thyroxine \\[T4\\], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.\n\nCTDS EC: ASP2138 in Combination with Ramucirumab \\& Paclitaxel as Second-line Therapy in Gastric\u002FGEJ Cancer:\n\n* History of cerebrovascular accident or transient ischemic attack within 6 months prior to study intervention.\n* Participant has significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study intervention.\n* Participant has evidence of a bleeding diathesis or significant coagulopathy.\n* Participant has initiated new treatment with medications that affect the coagulation cascade with an INR ≥ 2 such as vitamin K antagonists, heparins \\& direct thrombin inhibitors or the use of factor Xa inhibitors within 28 days prior to the start of study intervention.\n\nNote: If the participant started receiving such medications more than 28 days prior to the start of study intervention \\& needs to continue, this is allowed. However, new anticoagulation medications may not be initiated within 28 days prior to the start of study intervention.\n\nJapan \\& Korea Specific:\n\nFor All Participants in ASP2138 in Combination with Pembrolizumab \\& CAPOX:\n\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab \\& CAPOX \\[all components\\]).\n* Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded, however, participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast or for chemotherapy (as part of CT administration) are allowed.\n* Participant is known to have HIV infection.\n* NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells\u002FμL \\& no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.\n* Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention.\n* Participant has a history of ascites requiring drainage more than twice in the past 7 days.\n* Participant has known DPD deficiency.\n\nCTDS EC:\n\nASP2138 in Combination with Pembrolizumab \\& CAPOX as First-line Therapy in Gastric\u002FGEJ Cancer:\n\n* Participant has history of (noninfectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant received live-virus vaccination within 30 days prior to the first dose of study intervention.\n* Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Participants who require replacement therapy (e.g., thyroxine \\[T4\\], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.",{"count":392,"type":20},398,[23],"Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This \"tells\" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments.\n\nThe main aims of the study are:\n\n* To check the safety of ASP2138 and how well people can tolerate medical problems during the study.\n* To find a suitable dose of ASP2138 to be used later in the study.\n* These are done for ASP2138 given by itself and when given together with the standard cancer treatments.\n\nAdults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a \"trigger\" such as infection, or have a specific heart condition (\"New York Heart Association Class III or IV\").\n\nPhase 1: Lower to higher doses of ASP2138\n\n* ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection).\n* Different small groups are given lower to higher doses of ASAP2138.\n* ASP2138 is either given by itself, or given with 1 of 3 standard treatments:\n* Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer)\n* Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer)\n* ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer)\n\nPhase 1b: doses of ASP2138 worked out from Phase 1\n\n* ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1.\n* People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1.\n* This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments.\n* The standard cancer treatments given depends on the type of cancer they have.\n\nEnd of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment.\n\nPeople who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself.",[396,397,32],"Gastric Adenocarcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma",[399,400,401,402,403],"Claudin (CLDN) 18.2","ASP2138","Pharmacokinetics","Safety","Tolerability",{"date":381,"type":53},{"date":406,"type":53},"2022-06-07",{"date":408,"type":20},"2028-05-31",{"name":158,"class":96},46,{"id":412,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":413,"targetDuration":4,"studyType":21,"phases":414,"briefSummary":25,"conditions":415,"keywords":416,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":421,"leadSponsor":422,"locationsCount":61},"100439284",{"count":19,"type":20},[23,24],[27,28,29,30,31,32,33,34,35],[37,38,39,40,41,42,43,44,45,46,47,48],"2026-06-04",{"date":419,"type":53},"2026-06-05",{"date":55,"type":53},{"date":57,"type":20},{"name":59,"class":60},{"id":424,"slug":4,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":21,"phases":431,"briefSummary":432,"conditions":433,"keywords":438,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":129},"100619816","NCT07349537","Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Phase 1\u002F1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.\n* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.\n* Measurable per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and\u002For inhibitors).\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":430,"type":20},574,[23],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.",[434,435,32,232,230,183,189,228,436,437],"Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Lung Cancer (NSCLC)","Advanced Solid Tumors",[437,228,236,230,112,183,439,73,189,237,238,242],"Lung Cancer","2026-05-28",{"date":442,"type":53},"2026-06-01",{"date":444,"type":53},"2026-01-08",{"date":446,"type":20},"2028-10",{"name":250,"class":96},{"id":449,"slug":4,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":21,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":61},"100640601","NCT07619391","MyCap Mobile Application for Tracking Time Burden of Treatment for Patients With Pancreatic Cancer","A Mobile App for Tracking Time Burden of Pancreatic Cancer Treatment: A Single-Arm Feasibility Study","Inclusion Criteria:\n\n* Adults ≥ 18 years old\n* Diagnosed with pancreatic adenocarcinoma undergoing active treatment or planning to start active treatment within the next 30 days\n* English speaking\n* Access to a smartphone (Android or iOS)\n\nExclusion Criteria:\n\n* Prisoners\n* Patients undergoing cancer surveillance",{"count":455,"type":20},30,[293],"This clinical trial tests the feasibility of using the MyCap mobile application (app) for tracking time burden from treatment for patients with pancreatic cancer. Pancreatic cancer is best treated with many care teams, such as medical oncology and surgery, requiring patients to dedicate significant time coordinating appointments among different doctors. This time commitment is referred to as time toxicity, defined as the time spent undergoing cancer-related medical care, such as emergency visits, ambulatory care, lab and infusion visits, hospitalizations, and the commuting and waiting times associated with each. At present, time toxicity is still understudied within the medical literature, with no gold standard established for the method of measurement. The MyCap mobile app may be a feasible way to track the time burden from treatment for patients with pancreatic cancer.",[32],"2026-05-27",{"date":461,"type":53},"2026-06-02",{"date":463,"type":53},"2026-03-10",{"date":465,"type":20},"2027-12-31",{"name":467,"class":60},"Ohio State University Comprehensive Cancer Center",{"id":469,"slug":4,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":21,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":61},"100639729","NCT07594067","TCR1188-ABC Cells in KRAS-mutated Cancers","Phase I, Open-Label Study of Autologous Mutant KRAS and ILT4-Redirected T-cell Receptor Cells (TCR1188-ABC)","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age\n2. Patients with one of the following diagnoses:\n\n   1. Histologically confirmed metastatic pancreatic adenocarcinoma or cholangiocarcinoma\n   2. Histologically confirmed metastatic colorectal cancer\n   3. Histologically confirmed metastatic non-small cell lung cancer\n3. HLA-A\\*11:01 positive as confirmed by a CLIA certified laboratory.\n4. KRAS G12V mutation positive disease as confirmed on tissue, blood, or plasma by next generation sequencing by a CLIA certified laboratory.\n5. Received prior treatment for their primary malignancy as follows:\n\n   1. Pancreatic Cancer\u002FCholangiocarcinoma Patients: At least one prior line of standard of care therapy for advanced stage disease. For pancreatic cancer patients, this must include a gemcitabine or fluorouracil (5 FU)-based regimen.\n   2. Colorectal Cancer Patients: At least three prior lines of standard of care therapy for advanced stage disease. Prior treatment must include all of the following unless the patient was ineligible for a specific therapy type: i). a fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimen, ii). an anti-vascular endothelial growth factor (VEGF) agent, and iii). regorafenib, trifluridine-tipiracil, or fruquintinib. Patients with microsatellite instability-high (MSI-H) disease must also have received, or be ineligible for, prior treatment with an immune checkpoint inhibitor.\n   3. Non-Small Cell Lung Cancer Patients: At least one prior line of standard of care therapy for advanced stage disease.\n6. Evidence of radiographically detectable disease within 8 weeks of physician-investigator confirmation of eligibility.\n7. Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as:\n\n   1. Serum creatinine ≤ 1.5 mg\u002Fdl or creatinine clearance ≥ 50 cc\u002Fmin per the Cockcroft-Gault Equation; Patient must not be on dialysis.\n   2. ALT\u002FAST ≤ 5 x ULN (patients with liver metastases) or ALT\u002FAST ≤ 2.5 x ULN (patients without liver metastases)\n   3. Total bilirubin ≤ 1.5 mg\u002FdL x ULN, unless the subject has Gilbert's syndrome (if so, direct bilirubin must be ≤ 2.0 mg\u002FdL x ULN)\n   4. Left Ventricle Ejection Fraction (LVEF) ≥ 50% confirmed by ECHO\u002FMUGA\n   5. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \\> 92% on room air\n8. Patients must have adequate hematologic reserve within 4 weeks of eligibility confirmation by a physician-investigator and must not be dependent on transfusions to maintain these hematologic parameters. Adequate hematologic reserve is defined as:\n\n   1. Hemoglobin ≥ 8 g\u002FdL\n   2. Absolute neutrophil count ≥ 1000\u002FμL\n   3. Platelet count ≥ 100,000\u002FμL\n9. ECOG Performance Status that is either 0 or 1.\n10. Signed, written informed consent\n\nExclusion Criteria:\n\n* 1\\. Active hepatitis B or hepatitis C infection 2. Patients with a severe acquired or inherited immunodeficiency, including HIV positive patients with a CD4 count ≤ 350 cells\u002FμL. In order to qualify, HIV positive patients must also be on an established antiretroviral therapy regimen with a viral load of \\\u003C400 copies\u002FmL.\n\n  3\\. Any other active, uncontrolled infection. 4. Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification.\n\n  5\\. Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study.\n\n  6\\. Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to eligibility confirmation by a physician-investigator. \\[Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible\\].\n\n  7\\. Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods.\n\n  8\\. Patients requiring chronic treatment with systemic steroids or immunosuppressant medications. Low-dose physiologic replacement therapy with corticosteroids equivalent to prednisone 10 mg\u002Fday or lower, topical steroids and inhaled steroids are acceptable. For additional details regarding use of steroid and immunosuppressant medications.\n\n  9\\. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg daily of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.\n\n  10\\. Patients with unstable angina, serious uncontrolled cardiac arrhythmia, and\u002For mycocardial infarction within 6 months of physician-investigator confirmation of eligibility.\n\n  11\\. Prior history of myocarditis. 12. Patients with pneumonitis\u002Finterstitial lung disease requiring steroid treatment.\n\n  13\\. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) or tocilizumab.",{"count":455,"type":20},[23],"This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1188-ABC cells in patients with KRAS-mutated cancers. Initially, patients with KRAS G12V mutation positive metastatic pancreatic adenocarcinoma, cholangiocarcinoma, colorectal cancer, or non-small cell lung cancer (NSCLC) will be targeted for participation. Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.",[143,112,110,32],"2026-05-11",{"date":480,"type":53},"2026-05-18",{"date":482,"type":20},"2026-07",{"date":484,"type":20},"2042-07",{"name":486,"class":60},"University of Pennsylvania",{"id":488,"slug":4,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":21,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":505,"leadSponsor":507,"locationsCount":61},"100639830","NCT07583771","A Phase Ⅰ Study of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma","A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic and Preliminary Efficacy of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma","Inclusion Criteria:\n\n1. Understand and sign the informed consent form voluntarily.\n2. ≥18 years old when signing the informed consent, regardless of sex.\n3. Histologically or cytologically confirmed locally advanced or metastatic solid tumors, or relapsed\u002Frefractory lymphoma, for which standard therapy has failed or is not tolerated, and no further standard therapy is available. Homozygous MTAP or CDKN2A deletion confirmed by tissue or peripheral blood testing.\n4. For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. For lymphoma: at least one measurable lesion according to Lugano 2014 criteria.\n5. For glioblastoma: KPS score ≥60. For other solid tumors and lymphoma: ECOG performance status of 0 or 1.\n6. Adequate organ function.\n7. Life expectancy ≥3 months.\n8. Able to swallow and retain oral study medication.\n\nExclusion Criteria:\n\n1. Received any anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs\u002Fdevices that have not been approved for marketing within 28 days prior to the first dose or are still within 5 half-lives of such drugs (whichever is shorter).\n2. Previously received MAT2A or PRMT5 inhibitors.\n3. Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures.\n4. Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1.\n5. History of other primary malignancies within 5 years prior to the first dose.\n6. For solid tumors : The presence of active, clinically symptomatic central nervous system metastases or leptomeningeal metastases or spinal cord compression at screening.\n7. Primary central nervous system lymphoma or systemic lymphoma with CNS involvement.\n8. Evidence of interstitial lung disease, pulmonary fibrosis, or non-infectious pneumonitis requiring treatment on chest imaging at screening.\n9. Active infection requiring systemic anti-infective treatment at screening.\n10. Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms.\n11. Uncontrolled or significant cardiovascular disease.\n12. Poorly controlled diabetes.\n13. Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption.\n14. History of gastrointestinal perforation, fistula, peptic ulcer, bowel obstruction, or biliary obstruction within 6 months prior to the first dose.\n15. Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose; currently on anticoagulants; high-risk bleeding tendency at screening.\n16. Serious thromboembolic events within 6 months prior to the first dose.\n17. Active tuberculosis at screening.\n18. Active hepatitis B or hepatitis C at screening.HIV infection or syphilis infection at screening.\n19. Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.\n20. History of organ transplantation or allogeneic hematopoietic stem cell transplantation.\n21. History of alcohol abuse or drug abuse.\n22. Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.\n23. Pregnant or breastfeeding women.\n24. Other conditions deemed unsuitable for participation in this trial by the investigator.",{"count":494,"type":20},186,[23],"This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS08399 in participants with MTAP-deleted solid tumors and Lymphoma, and to recommended Phase 2 dose(s) (RP2D) of CS08399 in appropriate tumor(s).",[32,498,437,499,500],"Non Small Cell Lung Cancer","Lymphoma","Diffuse Large B-Cell Lymphoma (DLBCL)","2026-05-07",{"date":503,"type":53},"2026-05-13",{"date":277,"type":20},{"date":506,"type":20},"2030-01",{"name":508,"class":96},"Chipscreen Biosciences, Ltd.",{"id":510,"slug":4,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":515,"phases":4,"briefSummary":516,"conditions":517,"keywords":519,"overallStatus":531,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":534,"locationsCount":4},"100637017","NCT07573215","Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma","Expanded Access Program to Treat Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma With Daraxonrasib","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed PDAC with metastatic disease.\n* Evidence of active disease progression during or following the most recent line of systemic therapy for PDAC, based on investigator assessment.\n* At least one prior line of systemic therapy in the metastatic setting, which must include either a fluoropyrimidine-based or gemcitabine-based regimen.\n* Received and progressed, been intolerant to prior standard therapy, or no longer expected to benefit from standard therapies.\n* Adequate bone marrow, renal, hepatic, and coagulation functions.\n* Ineligible for, or unable to enroll in, another clinical trial of daraxonrasib, if available.\n* Able to take oral medications\n\nExclusion Criteria:\n\n* History of known central nervous system metastatic disease.\n* Concurrent systemic anticancer therapy.\n* Significant cardiovascular disease.\n* Major GI conditions that may affect the ability to take or absorb daraxonrasib (patients with prior Whipple procedure are eligible).\n* Active uncontrolled systemic infection.\n* Major surgery within 28 days before enrollment.\n* Additional inclusion and exclusion criteria may apply.","EXPANDED_ACCESS","This Expanded Access Program (EAP) is intended to provide daraxonrasib to eligible adult patients with previously treated metastatic pancreatic adenocarcinoma, who have no comparable or satisfactory alternative therapy and are unable to participate in an ongoing daraxonrasib clinical trial.",[230,231,518,228,229,233,32,234],"Metastatic Pancreas Adenocarcinoma",[520,521,522,523,524,525,526,527,528,529,237,238,229,233,234,32,530],"Expanded Access Program (EAP)","EAP","Daraxonrasib","RMC-6236","RMC-0706236","Metastatic pancreatic adenocarcinoma","Pancreatic ductal adenocarcinoma (PDAC)","RAS(ON) inhibitor","Unmet medical need","Pancreatic cancer","Compassionate Use","AVAILABLE","2026-05-01",{"date":501,"type":53},{"name":250,"class":96},{"id":536,"slug":4,"hasResults":11,"nctId":537,"briefTitle":538,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":540,"enrollmentInfo":541,"targetDuration":4,"studyType":21,"phases":543,"briefSummary":544,"conditions":545,"keywords":548,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":555,"leadSponsor":557,"locationsCount":61},"100636531","NCT07566897","A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of one of the following tumor types for which no further approved systemic treatment options are available:\n\n   1. Unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, that has progressed following:\n\n      * at least one prior line containing FOLFIRINOX and\u002For gemcitabine plus nab-paclitaxel, and\n      * at least one approved second-line regimen (e.g., 5-FU\u002Fleucovorin plus liposomal irinotecan), or where these regimens are not suitable due to contraindication or prior intolerance\n   2. Metastatic proficient mismatch repair \u002F microsatellite stable (pMMR\u002FMSS), BRAF V600E-negative colorectal adenocarcinoma, that has progressed following:\n\n      * at least one prior line of systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan, with or without anti-VEGF and, if RAS wild-type, with or without anti-EGFR, and\n      * at least one approved subsequent line of therapy with trifluridine-tipiracil, regorafenib or fruquintinib, or where these agents are not suitable due to contraindication or prior intolerance;\n   3. Metastatic clear cell renal cell carcinoma, that has progressed following:\n\n      * at least one prior PD-(L)1-based systemic regimen, and\n      * at least one VEGF-targeted tyrosine kinase inhibitor (TKI), or where these treatments are not suitable due to contraindication or prior intolerance\n2. Patients must have no further approved and available therapy options or be documented as ineligible or intolerant.\n3. Patients must have radiographic disease progression on\u002Fafter the last line of prior treatment.\n4. At least one unidimensionally measurable lesion as defined by RECIST v.1.1.\n5. Eastern cooperative oncology group (ECOG) performance status ≤ 2.\n6. Patient has an estimated life expectancy of at least 12 weeks.\n7. Hemoglobin \\> 10.0 g\u002FdL.\n8. Platelets ≥ 100 x 109\u002FL.\n9. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL.\n10. Negative TB test (e.g., Mantoux or Quantiferon assay).\n11. Documented negative test for HIV, HBV, HCV excluding active infection is needed. For HBV serology: the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and\u002For anti-HBc Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n12. Serum creatinine \\\u003C 1.5 x ULN and estimated Glomerular Filtration Rate (eGFR) value above 75 mL\u002Fmin\u002F1.73m2. An age-calibrated definition of Chronic Kidney Disease (CKD) has been proposed to distinguish age-related from disease-related changes in eGFR. For patients younger than 40 years, CKD is defined by estimated Glomerular Filtration Rate (eGFR) below 75 mL\u002Fmin\u002F1.73m2.\n13. All acute toxic effects (excluding alopecia) of any prior therapy must have been resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.5.0) Grade ≤ 1.\n14. Women Of Childbearing Potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to six months following the last study treatment administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner. Double-barrier contraception is required.\n15. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to six months following the last study treatment administration. Double-barrier contraception is required.\n16. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Patients with primary brain tumors, brain metastases or CNS disease will be excluded.\n2. Chemotherapy, immunotherapy, or radiation therapy at the tumor sites within 4 weeks prior to study treatment start.\n3. Active or history of autoimmune disease that might deteriorate when receiving an immunostimulatory agent.\n4. Previous or concurrent cancer type that is distinct from the cancer being evaluated in this study. Exception made for any other cancer curatively treated ≥ 2 years prior to study treatment start.\n5. Presence of active severe bacterial or viral infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n6. Impaired cardiocirculatory functions due to any of the following conditions:\n\n   a History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n\n   b Inadequately controlled cardiac arrhythmias including atrial fibrillation. c Heart insufficiency (\\> Grade II, New York Heart Association (NYHA) criteria). d Any abnormalities observed during baseline ECG and Echocardiogram investigations are considered clinically significant by the investigator.\n\n   e Uncontrolled hypertension defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg.\n\n   f Ischemic peripheral vascular disease (Grade IIb-IV).\n7. Known arterial aneurysms.\n8. INR \\> 3.\n9. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN). At the discretion of the investigator, an increased exclusion threshold for patients with liver metastasis can be accepted as follows: ALT, AST and ALP ≥ 5 x ULN.\n10. Known uncontrolled coagulopathy or bleeding disorder, if the subject is being treated for coagulopathy or bleeding disorder and has tests within screening limits, he\u002Fshe may be included.\n11. Known hepatic cirrhosis or severe pre-existing hepatic impairment (Child-Pugh class B or C).\n12. Moderate to severe respiratory failure.\n13. Patient requires or is taking systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma\u002FCOPD is not considered an exclusion criterion.\n14. Known history of allergy to an excipient in study medication (e.g. IL2, ruxolitinib) or other human proteins\u002Fpeptides\u002Fantibodies.\n15. Pregnancy or breast-feeding.\n16. Severe diabetic retinopathy.\n17. Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n18. Patient with iatrogenic or pathologic severe immune suppression.\n19. Requirement of concurrent use of other anti-cancer treatments or agents other than study medication.\n20. Patient taking herbal medications within 7 days prior to study treatment start.\n21. Anticoagulation therapy with P2Y12 antagonists (e.g., clopidogrel, ticagrelor) and vitamin K antagonists (e.g., phenprocoumon, warfarin).","75 Years",{"count":542,"type":20},96,[23],"This trial aims to address unmet medical needs in advanced solid tumors, specifically metastatic clear cell renal carcinoma, locally advanced or metastatic pancreatic adenocarcinoma, and metastatic colorectal adenocarcinoma.",[546,233,32,547],"Renal Carcinoma Metastatic","Metastatic Colorectal Carcinoma (mCRC)",[549,550],"Ruxolitinib","Advanced solid tumors","2026-04-28",{"date":553,"type":53},"2026-05-05",{"date":532,"type":20},{"date":556,"type":20},"2030-05",{"name":558,"class":96},"Philogen S.p.A.",{"id":560,"slug":4,"hasResults":11,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":21,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":573,"leadSponsor":575,"locationsCount":61},"100636397","NCT07565155","Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency","A Phase 2 Trial of Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency","Inclusion Criteria:\n\n1. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.\n2. ≥ 18 years of age.\n3. Histologically confirmed pancreas carcinoma with metastatic disease. Neuroendocrine neoplasms are not eligible. Adenosquamous, squamous and acinar histologies are allowed provided criteria #5 is fulfilled, and these histologies comprise no more than 10% of the total accrual.\n4. Measurable disease on baseline imaging by CT (or MRI where CT is contraindicated) based on RECIST 1.1.\n5. Documented germline mutation in BRCA1, BRCA2, PALB2, radiation sensitive protein 51 C (RAD51C), or radiation sensitive protein 51 D (RAD51D) that is known or predicted to be detrimental or lead to loss of function on a chemiluminescence immunoassay (CLIA)-approved assay (e.g. Invitae, Ambry, Myriad, Tempus).\n6. Must have an accessible tumor amenable to a safe biopsy where the major complication rate is ≤ 1.5% in the judgement of the investigator.\n7. Must have prior exposure and disease progression after at least one line of platinum-based chemotherapy. Platinum-based chemotherapy given in the neo-adjuvant or adjuvant setting also satisfies this requirement if progression occurs within 1 year of the end of adjuvant therapy.\n8. Prior receipt of a poly (ADP-ribose) polymerase (PARP) inhibitor is allowed but not mandatory.\n9. Life expectancy of at least 3 months.\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n11. Adequate organ function defined as the following laboratory values within 14 days of Cycle 1 Day 1:\n\n    1. Neutrophils \\>1000\u002FμL (stable off any growth factor within 4 weeks of first study treatment administration).\n    2. Platelets \\> 100 × 103\u002FμL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).\n    3. Hemoglobin \\> 8.0 g\u002FdL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).\n    4. Serum creatinine \\\u003C 1.5 × upper limit of normal (ULN), or creatinine clearance ≥30 mL\u002Fmin (measured or calculated using Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi)).\n    5. Aspartate aminotransferase (AST)\u002F alanine aminotransferase (ALT) \\\u003C 3.0 × ULN or \\\u003C 5.0 x ULN if liver metastases are present.\n    6. Total bilirubin \\\u003C 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of \\\u003C 3.0 × ULN).\n    7. Albumin ≥ 3.0 g\u002FdL.\n12. Female patients of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study medication) with repeat urine or serum pregnancy test of Day 1 of each cycle and at the end of treatment visit. Nonchildbearing potential is defined as: a. ≥ 50 years of age and has not had menses for greater than 1 year. b. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation. c. Status is post hysterectomy, bilateral oophorectomy, or tubal ligation. d. Female patients who are diagnosed with a tumor that is known to secrete human chorionic gonadotropin (HCG) must be certified not pregnant based on clinical evidence and investigator judgment.\n13. Female patients of child-bearing potential must agree to use highly effective contraceptive measures starting with the screening visit through 7 months after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n14. Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 7 months after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n15. Willing and able to comply with the requirements of the protocol.\n\nExclusion Criteria:\n\n1. Has received any prior therapy with an anti-PD-1\u002FPD-L1 antibody or an anti-cytotoxic T lymphocyte-associated (CTLA) protein 4 (anti-CTLA-4) antibody.\n2. Has clinically significant ascites defined as requiring 1 or more therapeutic paracenteses in the last 4 weeks prior to study entry.\n3. Grade 2 or higher peripheral neuropathy\n4. Clinically significant gastrointestinal disorders including:\n\n   1. Any history of gastrointestinal perforation unless the affected area has been deemed by the investigator to no longer be a risk for perforation.\n   2. History of clinically significant gastrointestinal bleeding within 4 weeks prior to initiation of study treatment.\n   3. History of acute pancreatitis within 4 weeks prior to the initiation of study treatment.\n   4. Diverticulitis that is clinically significant in the opinion of the investigator based on the extent or severity of known disease and\u002For the occurrence of clinically significant disease flares within 4 weeks prior to the initiation of study treatment administration.\n   5. Bowel obstruction or impending bowel obstruction within the past 3 months.\n5. Clinically significant (i.e. active) cardiovascular disease:\n\n   1. Cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n   2. Pericarditis or clinically significant pericardial effusion.\n   3. Any history of myocarditis.\n6. Known central nervous system (CNS) involvement as follows: a. Untreated CNS metastases. b. Leptomeningeal metastases. c. NOTE: Patients may be eligible if CNS metastases have been treated and patients have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment).\n7. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of study treatment (i.e. patients with a history of prior malignancy are eligible if treatment was completed at least 1 year before the first dose of study treatment and the patient has no evidence of disease). Patients with history of prior early-stage basal\u002Fsquamous cell skin cancer or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.\n8. Washout period prior to Cycle 1 Day1: Participants must recover from clinically significant adverse events from their more recent therapy or intervention prior to study enrollment.\n\n   No specific time windows are given.\n9. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n10. Symptomatic interstitial lung disease (ILD) or ILD which may interfere with detection and management of new immune-related pulmonary toxicity.\n11. History of allogeneic solid organ or stem cell transplant.\n12. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n13. Patients with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent), are permitted in the absence of active autoimmune disease.\n14. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e. with use of disease modifying agents or immunosuppressive drugs). Replacement therapy with thyroxine, insulin or physiologic corticosteroid replacement therapy is not considered systemic treatment for autoimmune disease.\n15. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n16. Breastfeeding patients.\n17. Note: All patients diagnosed with disease known to secrete HCG will test positive for pregnancy. Therefore, a positive pregnancy test is not exclusion criteria for these patients.\n\n    However, pregnancy negative status must be otherwise reasonably ascertained by other objective means.\n18. Active infection requiring treatment within 2 weeks of Cycle 1 Day1.\n19. HIV positive, except cluster of differentiation 4 (CD4) \\>200 and HIV viral load undetectable.\n20. Active hepatitis B or C infection:\n21. Patients with hepatitis B virus (HBV) infection are eligible if hepatitis B surface antigen and HBV DNA are negative.\n22. Patients with hepatitis C virus (HCV) infection are eligible if HCV RNA is negative.\n23. Participants with impaired decision-making capacity",{"count":291,"type":20},[24],"The purpose of this study is to determine the objective response rate (ORR) to lorigerlimab in patients with refractory pancreatic ductal adenocarcinoma (PDAC) and pathogenic germline variants (PGVs) in breast cancer type 1 or 2 susceptibility protein (BRCA1\u002F2), Partner and Localizer of BRCA2 (PALB2) and radiation sensitive protein 51 C or D (RAD51C\u002FD).",[32,569],"Homologous Recombination Deficiency","2026-04-27",{"date":155,"type":53},{"date":442,"type":20},{"date":574,"type":20},"2031-06-01",{"name":576,"class":60},"Peter Hosein, MD",{"id":578,"slug":4,"hasResults":11,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":21,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":61},"100629734","NCT07478523","FAPI-PET Value for the Initial Screening of Pancreatic and Biliary Cancers","Diagnostic Value of 68Ga-FAPI-46 PET\u002FCT in the Initial Work-up of Pancreatic and Biliary Cancers Eligible to a Curative Treatment","FAPDIG","Inclusion Criteria:\n\n* Population 1: De novo pancreatic adenocarcinoma (pathological evidence) or strong suspicion of de novo pancreatic adenocarcinoma on imaging, immediately resectable, borderline or locally advanced, potentially requiring curative treatment and non-metastatic (M0), according to reference staging. - Population 2: De novo cholangiocarcinoma eligible for curative treatment (pathological evidence) or strong suspicion of de novo pancreatic adenocarcinoma on imaging, non-metastatic (M0), according to reference extension assessment. according to reference extension report\n\nCriteria common to both populations:\n\n* Age \\>18 years at the time of signing the informed consent\n* Patient affiliated to a social security system\n* Free and informed consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)\n\nExclusion Criteria:\n\n* Tumor M+ or with suspicion of distant metastasis on standard staging.\n* Neoadjuvant treatment\n* History of other active cancer\n* Pregnant or breastfeeding woman\n* Person under legal protection (guardianship or curatorship)\n* Person unable to personally give consent\n* Person in an emergency situation\n* Exclusion period from another protocol\n* Person deprived of liberty by judicial or administrative decision",{"count":585,"type":20},120,[24],"Pancreatic cancer is one of the worst-prognosed cancers with a 5-year survival rate of less than 10%. Its incidence has been steadily increasing for several years in France and worldwide. Pancreatic adenocarcinoma may become the second leading cause of cancer mortality in the years 2030-2040. Current standard of care for pancreatic cancer imaging at initial workup comprise CT imaging and MRI. However, these imaging modalities lack sensitivity and accuracy, with an estimated rate of about 30% of patients either with visceral or lymph node metastasis discovered during planned surgery or with relapse occurring during the first 6 months after surgery suggesting occult metastasis at diagnosis. Therefore, there is a clear need for new imaging modalities at initial diagnosis for more adapted and individualized therapeutic decision.\n\nCholangiocarcinoma (or cancer of the bile ducts) also has a dismal prognosis with a 5-year survival rate of 7%. The therapeutic objective is to obtain a surgical resection R0 when possible which can be associated with improved survival of up to 40% in appropriately selected patients. However, surgical morbidity and mortality are high, especially in peri-hilar forms. The detection of lymph node metastasis beyond the hepatic hilum is crucial, as surgery is considered futile in this situation. Current standard imaging at initial work-up include CT and MRI that have limited performance in estimating surgical resecability with a sensitivity of 60% for detecting lymph nodes metastasis and 67% for detecting distant metastasis. Therefore, there is also here an unmet need for improved baseline imaging.\n\nIn summary, this project is focused on two digestive cancers with poor prognosis in which preoperative imaging accuracy remains today imperfect.\n\nTherefore, we aim to demonstrate, when compared with current standard imaging, that 68Ga-FAPI-46 PET\u002FCT performed at baseline imaging in pancreatic and biliary duct cancers, leads to a change in TNM classification and subsequently to a change in therapeutic management.\n\nTo our knowledge, this will be the first (or one of the first) structured multicenter prospective study to evaluate the additional and potentially decisive contribution of 68Ga-FAPI-46 PET\u002FCT carried out after a standard imaging workup at initial diagnosis of pancreatic and biliary duct cancers.\n\nIf the diagnostic superiority of 68Ga-FAPI-46 PET\u002FCT is confirmed, this study could lead to define a new standard of care for the imaging of these cancers with poor prognosis. The study should also help to set the ground for future theranostic approaches where 68Ga-FAPI-46 PET\u002FCT would help select patients for targeted radionuclide therapy.",[143,32],"2026-04-24",{"date":591,"type":53},"2026-04-30",{"date":593,"type":53},"2026-04-21",{"date":595,"type":20},"2029-03-21",{"name":597,"class":60},"University Hospital, Bordeaux",{"id":599,"slug":4,"hasResults":11,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":603,"eligibilityCriteria":604,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":21,"phases":606,"briefSummary":607,"conditions":608,"keywords":609,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":620},"100584646","NCT06892054","Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma","Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma With KRAS p.G12C Mutation","PANSOTO","Inclusion Criteria:\n\n1\\) Willing and able to provide informed consent. 2) Men or women aged ≥ 18 years old. 3) Using effective contraceptive measures or sexual abstinence during the treatment, up to 7 days after the last dose of sotorasib, for at least 6 months after the last dose of gem\u002Fnab-P and for 15 months after the last dose of mFOLFIRINOX for woman of childbearing age and 12 months after stopping mFOLFIRINOX for men:\n\n* Female of childbearing potential using a highly effective method of contraception (i.e., a method with less than 1% failure rate \\[e.g., sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner\\])\n* Male agreeing to use condoms or having a partner who is using a highly efficient method of contraception as described above 4) Pathologically confirmed treatment-naïve of locally advanced or metastatic pancreatic adenocarcinoma harboring KRAS p.G12C mutation assessed by means of a IVDR compliant test) 5) Measurable disease per RECIST 1.1 criteria. 6) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 7) Life expectancy \\> 3 months, in the opinion of the investigator. 8) Adequate hematologic, renal and hepatic organ function, defined as the following within 10 days prior study inclusion:\n* Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n* Hemoglobin ≥ 9.0 g\u002FdL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n* Platelet count ≥ 100 x 109\u002FL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n* Aspartate aminotransferase (AST) and ALT ≤ 2.5 times the upper limit of normal (ULN) or ≤5 times if liver metastasis\n* Serum bilirubin ≤ 1.5 x ULN\n* International normalized ratio (INR) ≤ 1.5 x ULN. Prothrombin time (PT) ≤ 1.5 x ULN may be used instead of INR for sites whose laboratory do not report INR\n* Creatinine clearance ≥ 30 mL\u002Fmin (estimated by Cockcroft-Gault equation) 9) Ability to take oral medications and willing to record daily adherence to investigational product.\n\nExclusion Criteria:\n\n1. Patients with resectable or borderline resectable pancreatic cancer.\n2. Known history or positive viral test for human immunodeficiency virus (HIV).\n3. Peripheral sensory neuropathy. 4 )Proven complete dihydropyrimidine dehydrogenase (DPD) deficiency for patients that will be treated with mFOLFIRINOX.\n\n5\\) Poor nutritional status (albumin \\\u003C3 g\u002FL or weight loss \\>10% during the last 4 weeks).\n\n6\\) Patients with known active hepatitis (i.e., Hepatitis B or C)\n\n* Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA 7) Female: currently pregnant or breast-feeding or who plan to breastfeed while on study though 7 additional days after the last dose of sotorasib and for at least 6 months afterwards after the last dose of gem\u002Fnab-P or 15 months after the last dose of mFOLFIRINOX.\n\n  8\\) Myocardial infarction within 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association \\> class II), unstable angina, or cardiac arrhythmia requiring medication 9) Prior anti-tumor treatment for metastatic or locally advanced pancreatic adenocarcinoma\\*. Prior chemotherapy or radiotherapy in the adjuvant or neoadjuvant setting is acceptable if received \\> 6 months prior to study enrolment\n\n  \\*If initiation of treatment is deemed urgent by the investigator, patients can receive 1st month of Standard of Care (SoC) gem\u002Fnab-P (1 cycle) or FOLFIRINOX (2 cycles) during screening. This first month of gem\u002Fnab-P or FOLFIRINOX is not a requirement of the study and is not part of this clinical study 10) Active infection requiring antibiotics within 1 weeks of study enrollment. 11) Other malignancy unless curatively treated with no evidence of disease for ≥2 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, and\u002For ductal carcinoma in situ.\n\n  12\\) Significant gastrointestinal disorder that results in significant malabsorption, requirement for IV alimentation, or inability to take oral medication.\n\n  13\\) History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.\n\n  14\\) Presence of any condition that, in the opinion of the investigator, renders the patient at high risk from treatment complications or might affect the interpretation of the results of the study.\n\n  15\\) Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk to patient safety, in the opinion of the investigator.\n\n  16\\) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Patients with PleurX catheters or intraperitoneal drainage catheters in place may be considered for the study with Medical Monitor approval.\n\n  17\\) Major surgery within 4 weeks of study Day 1 18) Prior\u002Fconcomitant therapy:\n* Previous treatment with a KRASG12C inhibitor\n* Use of warfarin. Other anticoagulation may be allowed\n* Use of known cytochrome P450 (CYP) 3A4 sensitive substrates and P-glycoprotein (P-gp) substrates (with a narrow therapeutic window), within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to study Day 1 (see examples of sensitive substrates and P-glycoprotein substrates in Appendix A) except for those investigational treatments administered as part of the study scheme that will be subject to specific PK analysis.\n* Use of strong inducers of CYP3A4 (including herbal supplements such as St John's wort) within 14 days or 5 half-lives (whichever is longer) prior to study Day 1 (see examples of strong inducers of CYP3A4 in Appendix A)\n* Live attenuated vaccines (against yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus and influenza), within 30 days prior of the first dose of study treatment.\n* Brivudine-based treatments within 4 weeks before treatment with 5-fluorouracil. 19) Patient has known sensitivity to any of the products or components to be administered during the study.\n\n  20\\) History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.",{"count":310,"type":20},[23],"The main objective of this trial is to evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.",[32],[119,610,611,612],"sotorasib","TTD-24-01","KRASG12C",{"date":591,"type":53},{"date":615,"type":53},"2025-08-08",{"date":617,"type":20},"2030-08-08",{"name":619,"class":60},"Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)",26,{"id":622,"slug":4,"hasResults":11,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":21,"phases":630,"briefSummary":631,"conditions":632,"keywords":634,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":61},"100553243","NCT06483555","Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel","Subjects With Advanced Basal-like Pancreatic Adenocarcinoma Treated With Gemcitabine, Erlotinib and Nab-paclitaxel (PANGEA) Versus Subjects With Classical Pancreatic Adenocarcinoma Treated With Triplet Standard of Care Therapy.","PANGEA","Inclusion Criteria:\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Histological or cytological evidence\u002Fconfirmation of unresectable, borderline resectable, or metastatic (basal-like and classical) pancreatic adenocarcinoma.\n* The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.\n* Subjects may have received prior standard-of-care (SOC) neoadjuvant therapy and may have received up to two cycles of first-line FOLFIRINOX or NALIRIFOX.\n* A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study treatment have been off of corticosteroids for ≥ 2 weeks and are asymptomatic.\n\nExclusion Criteria:\n\n* Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1\n* Not having histological or cytological evidence\u002Fconfirmation of metastatic pancreatic adenocarcinoma.\n* Treatment with any investigational drug or prior cancer treatment within 28 days prior to study treatment",{"count":629,"type":20},104,[23,24],"This Phase I\u002FII clinical trial is being conducted at multiple centers to find out whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab paclitaxel (GnP) is safe, tolerable, and helpful for people with advanced pancreatic cancer. All participants are first tested with a tool called PurIST, which classifies tumors as either \"basal-like\" or \"classical.\" People with basal-like tumors will receive GnP plus erlotinib during Phase I so researchers can determine the safest and most effective dose. Once that dose is identified, the study moves to Phase II, where people with basal-like tumors will be randomly assigned to receive either GnP alone or GnP with erlotinib. Phase II may also test new drug combinations if new treatments become approved during the study period. Overall, the trial plans to include up to about 52 basal-like patients in Phase I, roughly 82 basal-like patients in Phase II, and at least 52 classical patients, with the possibility of enrolling more if needed. People whose tumors are classified as classical will continue with standard treatments recommended by their doctors or other clinical trials. Across the entire study, researchers will carefully track long-term outcomes such as overall survival, how long patients live before the cancer progresses, and how well their tumors respond to treatment.",[32,296,633],"Basal Cell Neoplasm",[635,636,637,638,269,270],"safety","tolerability","efficacy","EGFR inhibitors","2026-04-22",{"date":641,"type":53},"2026-04-23",{"date":643,"type":53},"2025-02-06",{"date":645,"type":20},"2027-08",{"name":647,"class":60},"UNC Lineberger Comprehensive Cancer Center",""]