[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Thailand\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":669},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,443,0,25,[9,41,65,85,107,138,161,182,207,228,257,287,308,373,397,433,455,476,497,517,543,564,587,610,641],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054324",false,"NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE","18 Years",{"count":19,"type":20},1440,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[26,27],"Prostate Cancer","Prostatic Neoplasms","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2025-05-13",{"date":36,"type":20},"2031-01-06",{"name":38,"class":39},"Merck Sharp & Dohme LLC","INDUSTRY",290,{"id":42,"slug":4,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100054215","NCT05744921","A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works","An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria","ACCESS-EXT","Key Inclusion Criteria:\n\nPatients Entering from the Parent Study\n\n1. Patients with PNH who have completed, without permanent discontinuation, study treatment in the parent study (R3918-PNH-2021\\[NCT05133531\\]), including the post-Open-label treatment period (OLTP) transition period, if applicable.\n2. Willing and able to comply with clinic visits and study-related procedures, including meningococcal vaccinations required per protocol.\n\nPatients Entering with C5 polymorphism\n\n1. Patients with PNH who have a documented C5 polymorphism rendering them refractory to eculizumab or ravulizumab (eg, p.Arg885His, p.Arg885Cys), as described in the protocol\n2. Diagnosis of PNH confirmed by high-sensitivity flow cytometry testing with PNH granulocytes or monocytes\n3. Active disease, as defined by the presence of 1 or more PNH-related sign or symptom as described in the protocol\n4. LDH level ≥2 × upper limit of normal (ULN) at the screening visit\n5. Willing and able to comply with clinic visits and study-related procedures, including meningococcal vaccinations required per protocol\n\nKey Exclusion Criteria:\n\nPatients Entering from the Parent Study\n\n1. Significant protocol deviation(s) in the parent study based on the investigator's judgment and to the extent that these would (if continued) impact the study objectives and\u002For safety of the patient\n2. Any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study\n\nPatients Entering with C5 polymorphism\n\n1. Prior treatment with complement inhibitors within 5 half-lives of the respective agent prior to screening, except for prior eculizumab or ravulizumab which are not exclusionary\n2. Receipt of an organ transplant, history of bone marrow transplantation or other hematologic transplant\n3. Not meeting meningococcal vaccination requirements and, at a minimum, documentation of quadrivalent meningococcal vaccination within 5 years prior to enrollment and serotype B vaccine within 3 years prior to enrollment as described in the protocol\n4. Positive hepatitis B surface antigen or hepatitis C virus Ribonucleic acid (RNA) during screening\n5. Patients with known HIV with history of opportunistic infections in the last 1 year as described in the protocol\n6. Known hereditary complement deficiency\n7. Documented history of active, uncontrolled, ongoing systemic autoimmune diseases\n8. Documented history of liver cirrhosis or patients with liver disease with evidence of current impaired liver function or patients with elevations in Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) (unrelated to PNH or its complications) as described in the protocol\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply","ALL",{"count":50,"type":20},202,[23],"This study is researching an experimental treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of this study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH in the long term. The pozelimab + cemdisiran combination may be referred to as \"study drugs\" in this section.\n\nThis study is looking at several other research questions, including:\n\n* How effective is the pozelimab + cemdisiran combination?\n* What side effects may happen from taking the study drugs?\n* How much of each study drug is in the blood at different times?\n* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)",[54],"Paroxysmal Nocturnal Hemoglobinuria",[56],"PNH",{"date":31,"type":32},{"date":59,"type":32},"2023-03-07",{"date":61,"type":20},"2029-02-26",{"name":63,"class":39},"Regeneron Pharmaceuticals",45,{"id":66,"slug":4,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100053831","NCT06979596","A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015\u002FOMAHA-015)","A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Cohort A:\n\n  * Has a diagnosis of hormone receptor positive\u002FHuman Epidermal Growth Factor Receptor 2 negative (HR+\u002FHER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent.\n  * Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting and received either, 1 line of an approved protocol-specified combination endocrine-based therapy, or 2 or more lines of protocol-specified endocrine-based therapy in the metastatic setting\n* Cohort B:\n\n  * Has histologically confirmed high-grade epithelial (including high-grade serous or predominantly serous, high-grade endometrioid, malignant mixed Müllerian tumors \\[carcinosarcoma\\], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma.\n  * Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line (3L) setting for ovarian cancer.\n* Cohort C:\n\n  * Histologically confirmed diagnosis of primary advanced or recurrent low-grade endometrioid carcinoma (eg, Federation of Gynecology and Obstetrics \\[FIGO\\] Grade 1\u002F2, or well\u002Fmoderately differentiated).\n  * Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced\u002Fmetastatic OR adjuvant\u002Fneoadjuvant setting.\n* All Cohorts :\n\n  * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.\n  * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.\n  * Participants who are Hepatitis B surface antigen positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load.\n  * Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Cohort A:\n\n  * Breast cancer amenable to treatment with curative intent.\n  * Has advanced\u002Fmetastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, radiographic evidence of intratumoral cavitation or invasion\u002Finfiltration of a major blood vessel, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.\n* Cohort B:\n\n  * Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, low-grade serous, low-grade endometrioid, and undifferentiated carcinoma.\n  * Has platinum-resistant ovarian cancer (defined as disease that has progressed per radiographic imaging within 180 days after the last dose of first-line \\[1L\\] platinum-based therapy) or platinum-refractory ovarian cancer (defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).\n  * Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.\n* Cohort C:\n\n  * Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinoma and nonendometrioid histologies of any type (including serous, clear cell, mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterine mesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas, and adenosarcomas are not eligible.\n  * Is a candidate for curative-intent surgery or curative-intent radiotherapy.\n* All Cohorts:\n\n  * Has confirmed or suspected adrenal metastases.\n  * Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.\n  * Has any prior history or current condition of adrenal insufficiency.\n  * HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n  * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n  * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n  * Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n  * Has a history of stem cell\u002Fsolid organ transplant.\n  * Has not adequately recovered from major surgery or has ongoing surgical complications.",{"count":72,"type":20},250,[74],"PHASE2","Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer. MK-5684, the study medicine, is designed to treat cancer by blocking the body from making steroid hormones.\n\nResearchers will compare MK-5684 to the standard treatments for each cancer type in this study.\n\nThe goal of this study is to learn if people who receive MK-5684 live longer without the cancer growing or spreading compared to people who receive a standard treatment.",[77],"Malignant Neoplasm",{"date":31,"type":32},{"date":80,"type":32},"2025-08-11",{"date":82,"type":20},"2027-11-04",{"name":38,"class":39},57,{"id":86,"slug":4,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100053951","NCT06858579","A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","CAPTIVATE","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out.\n2. Weight range between 40 kilograms (kg) and 120 kg.\n3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.\n4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.\n5. Must be neurologically stable.\n6. Must have an INCAT score between 2 and 9 inclusive.\n7. Must fulfill one of the following treatment conditions for CIDP:\n\n   1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \\[IVIg\\] or subcutaneous immunoglobulin \\[SCIg\\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.\n   2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.\n   3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and\u002For oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.\n   4. Treatment naïve with no history of prior treatment for CIDP.\n8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.\n9. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n10. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.\n\nExclusion Criteria:\n\n1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.\n2. Known evidence of central demyelination or known history of myelopathy.\n3. History or presence of significant medical\u002Fsurgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety\u002Fefficacy or study procedures.\n4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.\n5. Known complement deficiency or history of positive titer for anti-C1 antibodies.\n6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).\n7. Participants with an autoimmune disease affecting joints, muscle or nervous system.\n8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.\n9. Prior history of N. meningitidis infection.\n10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.\n11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.","75 Years",{"count":94,"type":20},256,[23],"The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).",[98],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":31,"type":32},{"date":101,"type":32},"2025-02-10",{"date":103,"type":20},"2030-12-31",{"name":105,"class":39},"Dianthus Therapeutics",180,{"id":108,"slug":4,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100053250","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":115,"type":20},450,[23],"Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[119,120],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[122,123,124,125,126,127,128,129],"NSCLC","Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":31,"type":32},{"date":132,"type":32},"2025-07-17",{"date":134,"type":20},"2029-12",{"name":136,"class":39},"Nuvalent Inc.",156,{"id":139,"slug":4,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":48,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100053821","NCT07298421","A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease","A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2-17 Years With Moderately to Severely Active Crohn's Disease","SIBERITE-PEDS","Inclusion Criteria:\n\n* Body weight \\>= 10 kilogram (kg)\n* Active CD confirmed by endoscopy (ileocolonoscopy)\n* Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \\>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \\>=6 (or \\>=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy\n* Inadequate response, loss of response, and\u002For intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and\u002For immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)\n\nExclusion Criteria:\n\n* Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)\n* History of \\>= 3 bowel resections: \\> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum\n* Current diagnosis of ulcerative colitis (UC), abdominal\u002Fintraabdominal\u002Fperianal fistula and\u002For abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.\n* Symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Current diagnosis or suspicion of primary sclerosing cholangitis","2 Years","17 Years",{"count":148,"type":20},100,[23],"This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).",[152],"Moderately to Severely Active Crohns Disease",{"date":31,"type":32},{"date":155,"type":20},"2026-08-31",{"date":157,"type":20},"2031-05-30",{"name":159,"class":39},"Hoffmann-La Roche",7,{"id":162,"slug":4,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},"100054283","NCT06717347","A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant",{"count":168,"type":20},1046,[23],"The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.",[172],"Diffuse Large B-Cell Lymphoma",[174],"Lymphoma, Large B-Cell, Diffuse",{"date":31,"type":32},{"date":177,"type":32},"2025-01-27",{"date":179,"type":20},"2032-03-29",{"name":38,"class":39},266,{"id":183,"slug":4,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100053849","NCT06589596","An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors","A Phase 1a\u002Fb Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination With Anticancer Agents in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must sign the ICF and be capable of giving written informed consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70\n* Life expectancy ≥ 3 months\n* Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue\n* Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing\n* Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose diseases have progressed or recurred after receiving standard systemic therapy or radiotherapy, or for whom standard systemic therapy is not available or tolerated, or would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard treatment in the opinion of the investigator; participants with advanced, metastatic, or unresectable solid tumors who have not received prior systemic treatment or have received one cycle of standard-of-care therapies will be enrolled in selected cohorts\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor\n* Active leptomeningeal disease or symptomatic spinal cord compression\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage\n* Any malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively\n* Significantly impaired pulmonary function\n* Clinically significant infections\n* Serologically active hepatitis B or C infection\n* Known HIV infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria\n* High cardiovascular risk factors\n* QTcF \\> 470 ms based on the screening triplicate 12-lead ECG records and\u002For a history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome)\n* Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized\n* Participants who are unable to swallow or with disease\u002Fprocedure significantly affecting gastrointestinal function\n* Female participants who are pregnant or are breastfeeding\n* Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed)\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":189,"type":20},525,[191],"PHASE1","This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.",[194],"Advanced Solid Tumor",[196,197,198],"advanced solid tumor","BGB-58067","MTAP deficiency",{"date":31,"type":32},{"date":201,"type":32},"2025-01-10",{"date":203,"type":20},"2027-09-30",{"name":205,"class":39},"BeOne Medicines",96,{"id":208,"slug":4,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":48,"minAge":213,"maxAge":146,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100053407","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days",{"count":215,"type":20},342,[74,23],"This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[219,220],"Heart Failure","Left Ventricular Systolic Dysfunction",{"date":31,"type":32},{"date":223,"type":32},"2023-05-31",{"date":225,"type":20},"2032-04-15",{"name":38,"class":39},107,{"id":229,"slug":4,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100053363","NCT07699328","A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer","A Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)","REACH-EGFR","Inclusion Criteria:\n\n* Adults aged 18 years or older (19 years or older in the Republic of Korea).\n* Able to understand, sign, and provide written informed consent.\n* Histologically or cytologically confirmed advanced, metastatic, or recurrent predominantly nonsquamous non-small cell lung cancer (NSCLC) with a documented epidermal growth factor receptor (EGFR) mutation.\n* At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n* Documented EGFR mutation determined by tumor tissue or liquid biopsy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Able to swallow oral capsules and comply with study procedures.\n* Women of childbearing potential must have a negative pregnancy test, must not be breastfeeding, and must agree to use effective contraception during the study and for 7 months after the last safety follow-up visit. Men must agree to use effective contraception during the study and for 6 months after the last safety follow-up visit.\n* No appropriate standard treatment options are available or standard treatment is not considered feasible, in the opinion of the investigator.\n* Participants must meet the disease-specific eligibility criteria for one of the following study groups:\n\n  * Phase 1a\n\n    * NSCLC with EGFR activating, resistant, uncommon, or complex mutations, including but not limited to exon 19 deletion (Del19), L858R, C797S, or other uncommon EGFR mutations.\n    * Radiographic disease progression following at least 2 cycles of prior EGFR tyrosine kinase inhibitor (TKI) therapy or discontinuation of prior EGFR TKI therapy because of toxicity, with no remaining standard therapy expected to provide clinical benefit.\n  * Phase 1b - Cohort A\n\n    * NSCLC with EGFR exon 19 deletion or L858R mutation plus a C797X resistance mutation following disease progression after first-line treatment with a third-generation EGFR TKI (including osimertinib, lazertinib, or aumolertinib).\n  * Phase 1b - Cohort B\n\n    * Treatment-naïve NSCLC with common EGFR mutations.\n  * Phase 1b - Cohort C\n\n    * NSCLC with atypical or uncommon EGFR mutations (including G719X, L861Q, S768I, E709X, R776H, L747S, or combinations of these mutations) previously treated with at least one systemic therapy, including an EGFR TKI, with no remaining standard therapy expected to provide clinical benefit.\n  * Phase 1b - Cohort D\n\n    * Treatment-naïve NSCLC with atypical EGFR mutations.\n\nExclusion Criteria:\n\n* Received an investigational anticancer therapy within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment.\n* Unresolved side effects from previous anticancer therapy greater than Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), except for Grade 2 peripheral neuropathy or alopecia.\n* Pregnant or breastfeeding, or planning to become pregnant during the study.\n* NSCLC with an EGFR or HER2 exon 20 insertion mutation.\n* Another active malignancy within the past 3 years, with the exception of adequately treated cancers considered cured.\n* Inadequate bone marrow, kidney, or liver function based on protocol-defined laboratory criteria.\n* Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment.\n* Active hepatitis B or hepatitis C infection, or known human immunodeficiency virus (HIV) infection.\n* Receipt of a live vaccine within 4 weeks before the first dose of study treatment.\n* Use of strong or moderate cytochrome P450 (CYP) 3A inhibitors or inducers, certain herbal supplements, or other prohibited medications within the protocol-defined washout period.\n* Major surgery within 4 weeks before the first dose of study treatment or incomplete recovery from major surgery.\n* Receipt of prior anticancer therapy within the protocol-defined washout period, including systemic therapy, immunotherapy, or radiotherapy.\n* Symptomatic or uncontrolled central nervous system (CNS) metastases or spinal cord compression requiring increasing doses of corticosteroids. Participants with treated and stable CNS metastases or asymptomatic CNS disease may be eligible.\n* Requirement for systemic corticosteroid therapy exceeding the protocol-defined limit.\n* Clinically significant cardiovascular disease, including prolonged QT interval, clinically significant arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, uncontrolled hypertension, reduced left ventricular ejection fraction, or use of medications known to prolong the QT interval.\n* History of interstitial lung disease, noninfectious pneumonitis requiring steroid treatment, or current interstitial lung disease or pneumonitis.\n* Inability to swallow oral capsules or gastrointestinal disorders that may interfere with absorption of study treatment.\n* Known allergy or hypersensitivity to VRN110755 or any of its components.\n* Alcohol or drug abuse within the previous 2 years or any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with study participation or interpretation of study results.\n* Use of proton pump inhibitors, histamine-2 receptor antagonists, or locally acting antacids within the protocol-defined washout period or inability to comply with protocol requirements for acid-reducing medications.\n* For Phase 1b and Phase 2 only: Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including MET or HER2 amplification; ALK, ROS1, NTRK, or RET fusion; or BRAF V600E or KRAS G12X mutation.",{"count":236,"type":20},315,[191,74],"This first-in-human, Phase 1\u002F2, multicenter, open-label, non-randomized study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC).\n\nThe study includes a Phase 1a dose-escalation portion, a Phase 1b dose-expansion portion, and a Phase 2 evaluation. The study is designed to determine the maximum tolerated dose and recommended Phase 2 dose of VRN110755 and to evaluate preliminary and confirmatory antitumor activity in patients with EGFR-mutant NSCLC, including patients with acquired resistance following EGFR tyrosine kinase inhibitor therapy.",[240],"EGFR-Mutant Non-Small Cell Lung Cancer",[122,242,243,244,245,246,247],"EGFR","Epidermal Growth Factor Receptor","Non-Small Cell Lung Cancer","EGFR Mutation","C797S","EGFR Tyrosine Kinase Inhibitor Resistance","2026-07-09",{"date":31,"type":32},{"date":251,"type":32},"2024-03-26",{"date":253,"type":20},"2029-01-01",{"name":255,"class":39},"Voronoi, Inc",29,{"id":258,"slug":4,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":21,"phases":265,"briefSummary":266,"conditions":267,"keywords":272,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":286},"100053935","NCT07699276","Steroid Sparing Regimen With Olanzapine and Palonosetron for Emetic Prevention for High Dose Cisplatin","Steroid-sparing Regimen With Olanzapine and Ondansetron to Prevent Emesis Caused by High Dose Cisplatin in Solid Cancer Patient : A Single Arm Phase II Study","Inclusion Criteria:\n\n* histologically confirmed solid malignancy\n* scheduled for first cycle of cisplatin at dosage of at least 50 mg\u002Fm2\n\nExclusion Criteria:\n\n* pregnancy\n* pelvic or abdominal radiation within 4 weeks\n* uncontrolled brain metastasis\n* other moderate or high emetic risk chemotherapy on day 2-5\n* untreated gut obstruction\n* known allergy or severe adverse effect from palonosetron or olanzapine\n* AST\u002F ALT \\> 2.5x or serum creatinine clearance less than 50 ml\u002Fmin",{"count":264,"type":20},95,[74],"A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting",[268,269,270,271],"Cancer (Solid Tumors)","Vomiting","Cisplatin","Olanzapine",[273,274,275,276],"cisplatin","chemotherapy induced nausea vomiting","dexamethasone sparing","olanzapine","2026-07-07",{"date":31,"type":32},{"date":280,"type":32},"2026-02-10",{"date":282,"type":20},"2027-11-15",{"name":284,"class":285},"Mahidol University","OTHER",1,{"id":288,"slug":4,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":307},"100624093","NCT07405151","A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)","A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L\u002F3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F","Inclusion Criteria:\n\n* Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)\n* Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC\n* Has measurable disease\n* If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy\n* Has adequate organ function\n\nExclusion Criteria:\n\n* Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype\n* Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention\n* Has clinically significant corneal disease\n* Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event\n* If infected with HIV, has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has uncontrolled or significant cardiovascular disease\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* Has any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids or has current diagnosis of ILD or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has active infection requiring systemic therapy other than those permitted.\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen",{"count":294,"type":20},60,[191,74],"The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.",[298],"Oesophageal Squamous Cell Carcinoma","2026-07-01",{"date":301,"type":32},"2026-07-02",{"date":303,"type":32},"2026-03-27",{"date":305,"type":20},"2028-06-12",{"name":38,"class":39},19,{"id":309,"slug":4,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":316,"briefSummary":317,"conditions":318,"keywords":325,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":372},"100607241","NCT07185997","Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations","A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)","Key Eligibility Criteria:\n\n* Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.\n* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.\n* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).\n* Patients who have received prior neo-adjuvant and\u002For adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.\n* Patients with asymptomatic CNS metastases are eligible.",{"count":315,"type":20},480,[23],"Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.",[319,320,321,322,323,324],"Non-Small-Cell Lung Cancer","Metastatic Non-Small-Cell Lung Cancer","Advanced Non-Small-Cell Lung Cancer","EGFR P-Loop and Alpha C-Helix Compressing","EGFR PACC","EGFR Uncommon Mutations",[326,327,328,329,330,331,332,333,334,122,335,336,337,338,339,340,341,342,343,124,242,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364],"Non-Small Cell Lung Cancer (NSCLC)","PACC","Firmonertinib","Furmonertinib","AST2818","FURMO-006","Drug-Therapy","Metastatic Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer","Osimertinib","Afatinib","metastatic NSCLC first-line treatment","Carcinoma NSCLC","Respiratory tract neoplasms","Bronchial Neoplasms","Protein Kinase Inhibitors","tyrosine kinase inhibitor (TKI)","Alflutinib","EGFR kinase domain mutations","EGFR activating mutation","EGFR mutation of unknown significance","Non-classical EGFR mutation","EGFR uncommon mutations","EGFR atypical mutations","G719X","S768I","E709X","E709_T710delinsD","G779F","L747X","V774M","L747P\u002FS","R776C\u002FH","G724S","E736K","I740_K745dup","N771G","K757M\u002FR","V769L\u002FM",{"date":301,"type":32},{"date":367,"type":32},"2025-12-17",{"date":369,"type":20},"2030-12",{"name":371,"class":39},"ArriVent BioPharma, Inc.",78,{"id":374,"slug":4,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":48,"minAge":380,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":21,"phases":383,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":396},"100599779","NCT07088926","A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","CLEAR","Inclusion Criteria:\n\n1. Participant must be ≥ 12 years of age at the time of signing the informed consent\u002Fassent\n2. Weight ≥ 35 kg\n3. Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.\n4. Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics\n5. Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization\n6. Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.\n7. Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening\n8. Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.\n9. Capable of giving signed informed consent\u002Fassent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n\nExclusion Criteria:\n\n1. Primary lung diagnosis other than bronchiectasis\n2. Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy\n3. Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment\n4. Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed\n5. Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment\n6. AIDS or Advanced human immunodeficiency virus disease (CD4 count of \\\u003C 200 cells\u002Fmm3)\n7. History of severe adverse reaction associated with a mAb, and\u002For history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine\u002Fadrenaline or hospitalization), and\u002For history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration\n8. Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening\n9. Chronic immunosuppressive therapy (including prednisolone \\> 5 mg or equivalent) newly initiated within the last 3 months\n10. Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study\n11. Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening\n12. Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration","12 Years",{"count":382,"type":20},435,[74],"AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.",[386],"Bronchiectasis With Pseudomonas Aeruginosa Colonization",[388],"Bronchiectasis Chronic Pseudomonas Aeruginosa Colonization",{"date":301,"type":32},{"date":391,"type":32},"2025-11-06",{"date":393,"type":20},"2028-06-14",{"name":395,"class":39},"AstraZeneca",185,{"id":398,"slug":4,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":48,"minAge":403,"maxAge":404,"enrollmentInfo":405,"targetDuration":4,"studyType":21,"phases":407,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":432},"100588961","NCT06948214","Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency","A Multicenter, 12-Month, Randomized, Double Blind, Placebo-Controlled Phase 3 Efficacy and Safety Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)","Inclusion Criteria:\n\n* Subjects must be naïve to treatment and prepubertal\n* Subjects must have a maximal GH response of \\\u003C 10 ng\u002FmL from 2 prior GH stimulation tests conducted within the preceding 12 months\n* Impaired height defined as ≥ 2.0 standard deviations (SDs) below the mean height for chronological age and sex\n* Morning or random cortisol level of ≥ 7.0 μg\u002FdL\n* ≥ 3.0 years and age ≤ 10.0 years for girls and ≤ 11.0 years for boys\n* Baseline height velocity (HV) based on ≥ 6 months of growth assessments \\\u003C 25th percentile for age and sex\n* Bone Age delay of ≥ 12 months compared to the chronological age\n* In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic testing results are available, they need to be negative.\n* Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 3 months prior to Day 1\n* Baseline IGF-1 standard deviation score (SDS) ≤ -1.0\n\nExclusion Criteria:\n\n* Any medical or genetic condition which, in the opinion of the Investigator or Medical Monitor (MM), can be an independent cause of short stature and\u002For limit the response to exogenous growth factor treatment.\n* Arm span to height ratio \\> 2 SDs below the mean for age and sex\n* A medical or genetic condition that, in the opinion of the Investigator and\u002For MM, adds unwarranted risk to use of LUM-201\n* Use of any medication that, in the opinion of the Investigator and\u002For MM, can independently cause short stature or limit the response to exogenous growth factors\n* Current inflammatory diseases requiring systemic corticosteroid treatment for \\> 2 consecutive weeks within the last 3 months prior to the Screening Visit\n* Use of hormone replacement therapy for any hormone deficiency other than thyroid deficiency\n* Any ECG at the Screening Visit noted to have a clinically significant abnormality, as confirmed by the MM\n* Any subjects suspected of having past or present intracranial tumor growth as confirmed by brain imaging prior to the Screening or Day 1 Visit\n* Any subject suspected of having intracranial hypertension (IH) as confirmed by fundoscopy and other assessments\n* Any subject with serum alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin \\> upper limit of normal (ULN)\n* Suspicion of absent pituitary function as evidenced by a maximal stimulated GH ≤ 3.0 ng\u002FmL on any prior standard of care GH stimulation test completed within 12 months\n* Body weight ≤ 14.0 kg\n* BMI \\\u003C -2 or \\> +2 SDs for age and sex based on WHO standards\n* Birth weight for gestational age \\\u003C 3rd percentile based on WHO standards\n* Treatment with medications known to be moderate or strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A\u002F4\n* History of spinal, cranial, or total body irradiation\n* Attention deficit hyperactivity disorder (ADHD) diagnosis","3 Years","11 Years",{"count":406,"type":20},150,[23],"The OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive enrichment marker (LUM-201 PEM) strategy to select subjects likely to respond to therapy with daily oral LUM-201.",[410],"Growth Hormone Deficiency (GHD)",[412,413,414,415,416,417,418,419,420,421,422,423,424],"GHD","Pediatric Growth Hormone Deficiency","LUM-201","Growth hormone secretagogue","Height","Catch-up growth","PEM","Oral","Predictive Enrichment Marker","ibutamoren mesylate","OraGrowtH Phase 3 Trial","LUM-201 PEM","GH secretagogue",{"date":301,"type":32},{"date":427,"type":32},"2026-05-20",{"date":429,"type":20},"2028-01",{"name":431,"class":39},"Lumos Pharma",37,{"id":434,"slug":4,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":21,"phases":442,"briefSummary":443,"conditions":444,"keywords":446,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":454},"100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":441,"type":20},15100,[23],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[445],"Cardiovascular Disease",[447],"Atherosclerotic Cardiovascular Disease",{"date":301,"type":32},{"date":450,"type":32},"2025-06-04",{"date":452,"type":20},"2029-10-26",{"name":395,"class":39},1365,{"id":456,"slug":4,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":21,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":475},"100580113","NCT06833073","A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011\u002FINTerpath-011)","A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n\\- Is an individual whose most recent TURBT was performed within 12 weeks before randomization\u002Fallocation and showed BICR-confirmed high-risk NMIBC histology\n\nCohort A:\n\n* Has high-risk non-muscle invasive (HG Ta, T1, and\u002For CIS) UC of the bladder\n* Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG\n\nCohort B:\n\n* Has CIS +\u002F-papillary non-muscle invasive UC of the bladder\n* Is ineligible for, or refusing, any IVESIC therapy\n* Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG\n* Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC\n* Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions\n* Has a known additional malignancy that is progressing or has required active treatment within the last 3 years\n* Has had a myocardial infarction within 6 months of randomization\u002Fallocation\n* Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization\u002Fallocation\n* Has received prior treatment with a cancer vaccine\n* Has immunodeficiency or is receiving chronic systemic steroid therapy\n* Has active autoimmune disease that has required systemic treatment in the last 2 years\n* Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU)\n\nCohort A:\n\n* Has current active tuberculosis\n* Has a known history of HIV infection\n\nCohort B:\n\n\\- HIV-infected individuals with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease",{"count":462,"type":20},308,[74],"Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder.\n\nThe standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer.\n\nThe goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.",[466,467,468],"Urinary Bladder Neoplasms","Non-Muscle Invasive Bladder Neoplasms","Carcinoma in Situ",{"date":301,"type":32},{"date":471,"type":32},"2025-03-11",{"date":473,"type":20},"2031-09-03",{"name":38,"class":39},89,{"id":477,"slug":4,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":48,"minAge":483,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":21,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":496},"100579098","NCT06819878","A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease","A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease","SIBERITE-1","Inclusion Criteria:\n\n* Confirmed diagnosis of CD\n* Moderately to severely active CD\n* Bodyweight \\>= 40 kilogram (kg)\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced CD therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis\n* Participant with a history of \\>= 3 bowel resections (\\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)\n* Diagnosis of short gut or short bowel syndrome\n* Presence of an ileostomy, colostomy or ileoanal pouch\n* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \\>3 openings\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia\n* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy","16 Years","80 Years",{"count":486,"type":20},600,[23],"This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).",[152],{"date":301,"type":32},{"date":492,"type":32},"2025-03-17",{"date":494,"type":20},"2033-12-31",{"name":159,"class":39},372,{"id":498,"slug":4,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":48,"minAge":483,"maxAge":484,"enrollmentInfo":504,"targetDuration":4,"studyType":21,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":516},"100561337","NCT06588855","A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis","A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis","Ametrine-2","Inclusion Criteria:\n\n* Confirmed diagnosis of UC\n* Moderately to severely active UC assessed by mMS\n* Bodyweight \\>= 40 kilogram (kg)\n* Up to date with colorectal cancer (CRC) screening performed according to local standards\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced UC therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)\n* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis\n* Presence of an ostomy or ileoanal pouch\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed\n* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy",{"count":505,"type":20},350,[23],"This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).",[509],"Moderately to Severely Active Ulcerative Colitis",{"date":301,"type":32},{"date":512,"type":32},"2024-12-11",{"date":514,"type":20},"2031-01-30",{"name":159,"class":39},200,{"id":518,"slug":4,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":21,"phases":525,"briefSummary":526,"conditions":527,"keywords":529,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":542},"100535501","NCT06252649","Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation","Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)","CodeBreaK 301","Inclusion Criteria:\n\n* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.\n* Central laboratory detection of KRAS p.G12C mutation.\n* Measurable metastatic disease per RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Active, untreated brain metastases.\n* Leptomeningeal disease\n* Previous treatment with a KRAS p.G12C inhibitor\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan",{"count":115,"type":20},[23],"The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.",[528],"Metastatic Colorectal Cancer",[530,531,532,533,534],"Sotorasib","Panitumumab","FOLFIRI","Bevacizumab-awwb","Oncology",{"date":301,"type":32},{"date":537,"type":32},"2024-07-17",{"date":539,"type":20},"2032-04-25",{"name":541,"class":39},"Amgen",292,{"id":544,"slug":4,"hasResults":11,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":21,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":563},"100517384","NCT06016842","A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis","A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)","ELFIDENCE","Inclusion Criteria :\n\n* Male or female participants must be ≥18 years of age at the time of signing the informed consent.\n* Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC)\n* Participants with cirrhosis at SV1. • Participants must be Child Pugh A or Child Pugh B.\n* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria :\n\n* History or presence of other concomitant liver disease including but not limited to:\n\n  * i) Primary sclerosing cholangitis (PSC).\n  * ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) ≥6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA.\n  * iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative.\n  * iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be enrolled if a confirmatory HCV RNA is undetectable and sustained viral response has been documented).\n  * v) Alcohol-associated liver disease (ALD).\n  * vi) Nonalcoholic steatohepatitis (NASH).\n  * vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency.\n* History or presence of clinically significant hepatic decompensation, including:\n\n  * i) History of liver transplantation, current placement on a liver transplant list, current model for end-stage liver disease including (MELD) 3.0 score \\>12 due to hepatic impairment.\n  * ii) Evidence of complications of cirrhosis, including hepatic decompensation or evidence of significant portal hypertension complications including presence of uncontrolled ascites; history of variceal bleeding or related interventions (e.g. variceal banding, or transjugular intrahepatic portosystemic shunt placement); presence of hepatic encephalopathy Grade 2 or higher per West-Haven criteria; history or presence of spontaneous bacterial peritonitis. Note: participants with low-risk varices (Grade I) without history of bleeding or other treatment may be eligible to enrol.\n  * iii) Hepatorenal syndrome (HRS) (type I or II ). • vi) Hospitalisation for liver-related complication within 12 weeks prior to SV1.\n* Known history of human immunodeficiency virus (HIV) infection or having a positive confirmatory test for HIV type 1 or 2.\n* Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).\n* Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator; other clinically significant conditions that are not well controlled.\n* Non-hepatic medical conditions that may diminish life expectancy to \\\u003C2 years, including known cancers.\n* History of hepatocellular carcinoma.\n* Alpha-fetoprotein (AFP) \\>20 ng\u002FmL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of hepatocellular carcinoma.\n* Known malignancy or history of malignancy within the last 5 years. Participants with non-melanoma skin cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: • i) 3 months prior to baseline: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid or nitrofurantoin).\n* Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period.\n\n  i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer.ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent.\n* Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \\>450 msec in males or QTcF \\>470 msec in females for participants without bundle branch block. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF \\>480 msec would be exclusionary.\n* Total bilirubin (TB) \\>5x ULN\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>5x ULN at SV1\n* Creatinine phosphokinase (CPK) \\>2x ULN.\n* Platelet count \\\u003C50,000\u002FμL\n* International normalised ratio (INR) \\>1.8 in the absence of anticoagulant therapy.\n* Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m2 per the Modification of Diet in Renal Disease (MDRD)-6 Study formula at SV1.\n* Significant renal disease, including nephritic syndrome, chronic kidney disease (CKD) (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).\n* For female participants: known current pregnancy, or has a positive serum pregnancy test, or is breastfeeding.\n* Participants unwilling or unable to be abstinent from alcohol during the study.\n* History of alcohol abuse, or other substance abuse within 1 year prior to SV1.\n* Known hypersensitivity to elafibranor or to any of the excipients of the investigational product(s).\n* Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.\n* Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.\n* Alkaline phosphatase (ALP) ≥10x ULN.\n* Albumin \\\u003C2.8 g\u002FdL due to impaired hepatic function.",{"count":551,"type":20},276,[23],"The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver).\n\nPBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.\n\nThe liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.\n\nThis study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant.\n\nThe main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death).\n\nThis study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.",[555],"Primary Biliary Cholangitis (PBC)",{"date":301,"type":32},{"date":558,"type":32},"2023-08-31",{"date":560,"type":20},"2029-05-31",{"name":562,"class":39},"Ipsen",186,{"id":565,"slug":4,"hasResults":11,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":11,"sex":48,"minAge":570,"maxAge":571,"enrollmentInfo":572,"targetDuration":4,"studyType":21,"phases":574,"briefSummary":575,"conditions":576,"keywords":578,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":586},"100506775","NCT05878769","A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)","A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Completion of the 52-week treatment period in either parent GB43311 or GB44332\n\nExclusion Criteria:\n\n* Withdrawal of consent and\u002For premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment\n* Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study\n* Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study\n* Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study","40 Years","90 Years",{"count":573,"type":20},2000,[23],"The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.",[577],"Chronic Obstructive Pulmonary Disease",[579],"chronic obstructive pulmonary disease, COPD",{"date":301,"type":32},{"date":582,"type":32},"2023-06-28",{"date":584,"type":20},"2034-07-01",{"name":159,"class":39},486,{"id":588,"slug":4,"hasResults":11,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":21,"phases":596,"briefSummary":597,"conditions":598,"keywords":600,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":609},"100637445","NCT07611110","AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","VECTRA-01","Inclusion Criteria:\n\n* ≥ 18 years of age.\n* Diagnosis of adenocarcinoma of prostate.\n* Must have had prior orchiectomy and\u002For ongoing ADT and a castrate level of plasma\u002Fserum testosterone.\n* Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and\u002For non-measurable) that is suitable for repeated assessment by CT and\u002For MRI and\u002For bone scan.\n* Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.\n* Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC.\n* Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).\n* Positive PSMA PET\u002FCT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).\n* ECOG performance status of 0 to 2.\n* Adequate organ and bone marrow function as described in study protocol.\n* Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.\n* Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.\n\nExclusion Criteria:\n\n* Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).\n* Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.\n* Receipt of \\> 6 cycles of PSMA-directed β-emitting therapeutic RC.\n* History of another primary malignancy, with exceptions.\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.\n* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.\n* Clinically significant ECG abnormalities, with exceptions.",{"count":595,"type":20},670,[23],"The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.",[599],"Metastatic Castration-resistant Prostate Cancer",[601],"AZD2265; prostate cancer; mCRPC; PSMA; FPI-2265; 225Ac","2026-06-30",{"date":299,"type":32},{"date":605,"type":32},"2026-05-04",{"date":607,"type":20},"2029-12-20",{"name":395,"class":39},104,{"id":611,"slug":4,"hasResults":11,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":21,"phases":618,"briefSummary":619,"conditions":620,"keywords":624,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":640},"100626103","NCT07431281","Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2","A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced\u002FMetastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)","Inclusion Criteria:\n\n* Capable of giving signed informed consent\n* Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.\n* Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma\n* Positive CLDN18.2 expression, as determined prospectively by central IHC testing\n* Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:\n\n  1. Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.\n  2. Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible\n* ECOG performance status of 0 or 1 with no deterioration to \\> 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation.\n* Minimum life expectancy of ≥ 12 weeks.\n* At least one lesion (measurable and\u002For non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.\n* Adequate organ and bone marrow function as specified in the protocol\n* Body weight ≥ 35 kg.\n* Sex and contraceptive requirements\n\nExclusion Criteria:\n\n* Known HER2-positive status\n* Significant or unstable gastric bleeding and\u002For untreated gastric ulcers.\n* Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.\n* CNS pathology\n* Clinically significant pleural effusions or ascites and\u002For pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter\u002Fdrain.\n* Require parenteral nutrition support due to gastric or gastrointestinal obstruction.\n* Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening.\n* Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.\n* Cardiac abnormalities as outlined in the protocol\n* Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation.\n* Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and\u002For chronic or active hepatitis B with HBV DNA ≥ 100 IU\u002FmL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled\n* Known partial or total DPD enzyme deficiency",{"count":617,"type":20},2130,[23],"The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.",[621,622,623],"Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","Esophageal Cancer",[625,626,627,628,629,630,631,632,633],"Advanced Gastroesophageal Junction (GEJ) Adenocarcinoma,","Advanced Gastric Adenocarcinoma,","Advanced Esophageal Adenocarcinoma,","Metastatic Gastric Adenocarcinoma,","Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma,","Metastatic Esophageal Adenocarcinoma,","Claudin 18.2,","PD-L1,","Human epidermal growth factor receptor 2 (HER2) Negative",{"date":299,"type":32},{"date":636,"type":32},"2026-02-03",{"date":638,"type":20},"2031-10-27",{"name":395,"class":39},286,{"id":642,"slug":4,"hasResults":11,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":646,"eligibilityCriteria":647,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":21,"phases":650,"briefSummary":651,"conditions":652,"keywords":654,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":662,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":668},"100615317","NCT07291037","Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations","A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)","TROPION-Lung17","Inclusion Criteria:\n\n* Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC:\n\n  * Participants must have documented negative test results for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS proto-oncogene 1 (ROS1) genomic alterations.\n  * Has no known tumour genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition (MET) exon 14 skipping, Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C, human epidermal growth factor receptor 2 (HER2) or any other actionable driver oncogenes for which there are locally approved and available targeted first-line therapies.\n  * Prospectively assessed trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive.\n* Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.\n* Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)\u002Fanti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1\u002Fanti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.\n* Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2.\n* At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* Adequate bone marrow reserve and organ function within 7 days before randomisation.\n\nExclusion Criteria:\n\n* Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology.\n* NSCLC disease that is eligible for definitive local therapy alone.\n* History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence.\n* Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation.\n* Clinically significant corneal disease.\n* Has active or uncontrolled hepatitis B or C virus infection.\n* Known human immunodeficiency virus (HIV) infection that is not well controlled.\n* Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.\n* History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* Severe pulmonary function compromise per Investigator discretion.",{"count":649,"type":20},400,[23],"TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).",[653],"Non-small Cell Lung Cancer (NSCLC)",[646,655,656,657,658,659,660,661],"Non-small cell lung cancer (NSCLC)","Advanced non-squamous NSCLC","Metastatic non-squamous NSCLC","Datopotamab deruxtecan (Dato-DXd; DS-1062a)","Docetaxel","Trophoblast cell surface protein 2 (TROP2)","Normalised membrane ratio (NMR)",{"date":299,"type":32},{"date":664,"type":32},"2025-10-31",{"date":666,"type":20},"2029-01-29",{"name":395,"class":39},205,""]