[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-carcinoma":691},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,58,93,124,150,170,238,261,277,298,318,339,357,384,423,442,483,507,538,555,574,596,620,641,662],{"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":34,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100054097",false,"NCT05877599","A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicentre Platform Study to Evaluate the Safety and Preliminary Anti-tumour Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Participants With Advanced Malignancies That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria (Module 1)\n\n* Subjects must be at least 18 years of age\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria (Module 1)\n\n* Any another primary malignancy within the 3 years prior to enrollment\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.\n\nKey Inclusion Criteria (Module 2 - hematological malignancies)\n\n* At least 18 years of age\n* Diagnosis of AML or MDS that allows for efficacy assessments\n* Confirmation of TP53 R175H variant mutation in cancer cells\n* Subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* ECOG performance status of 0 to 1\n\nKey Exclusion Criteria (Module 2 - hematological malignancy)\n\n* Acute promyelocytic leukaemia or isolated extramedullary disease\n* Another primary malignancy within 2 years (with exceptions)\n* HSCT within 100 days or immunosuppression for GvHD within 4 weeks\n* History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells\n* Prior stroke, ischemic attack, significant cardiac disease, heart failure\n* Prior adoptive modified cell therapy\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.","ALL","18 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies",[26,27,28,29,30,31,32,33],"Non-small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Carcinoma","Pancreatic Adenocarcinoma","Breast Cancer","Other Solid Tumors","Ovarian Cancer","Myeloid Neoplasms (AML\u002FMDS)",[35,36,37,38,39,40,41,30,32,42,43,44],"Cell therapy","TP53","Solid tumors","Non-small cell lung cancer","Head and neck squamous cell carcinoma","Colorectal carcinoma","Pancreatic adenocarcinoma","AML","MDS","TCR","RECRUITING","2026-07-10",{"date":48,"type":49},"2026-07-13","ACTUAL",{"date":51,"type":49},"2023-07-12",{"date":53,"type":20},"2029-07-31",{"name":55,"class":56},"AstraZeneca","INDUSTRY",18,{"id":59,"slug":4,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":16,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100592628","NCT06995898","The Vanguard Study: Testing a New Way to Screen for Cancer","Inclusion Criteria:\n\n* Ages 45-75 years old\n* Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment\n* Agree to allow collection of information from their medical records for study-related purposes\n* Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic\n\n  * Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion\n\nExclusion Criteria:\n\n* Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years\n\n  * Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible\n* Ongoing cancer diagnostic work-up\n* Ongoing participation in another study of an investigational cancer screening test or technology\n* Currently breastfeeding or pregnant, or planning to become pregnant in the next year",true,"45 Years","75 Years",{"count":67,"type":20},24000,[69],"NA","The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).",[72,73,28,74,75,76,77,78,79,80,81],"Bladder Carcinoma","Breast Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Liver Carcinoma","Lung Carcinoma","Malignant Solid Neoplasm","Ovarian Carcinoma","Pancreatic Carcinoma","Prostate Carcinoma","2026-06-30",{"date":84,"type":49},"2026-07-01",{"date":86,"type":49},"2025-06-18",{"date":88,"type":20},"2029-06-30",{"name":90,"class":91},"National Cancer Institute (NCI)","NIH",38,{"id":94,"slug":4,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":57},"100532907","NCT06218914","Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor\n* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\\*08:02 positive, HLA-A\\*11:01 or HLA-A\\*11:02 positive in at least one allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Presence of at least 1 measurable lesion per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n\nKey Exclusion Criteria:\n\n* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment\n* Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRAS G12D mutation is confirmed after the completion of treatment with pan-KRAS or KRAS G12D targeting agents.",{"count":100,"type":20},108,[23],"Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and\u002For Metastatic Solid Tumors.",[26,28,104,105,106,107],"Pancreatic Ductal Adenocarcinoma","Endometrial Cancer","Solid Tumor, Adult","KRAS G12D",[109,110,107,111,112,113,114,37,104,115,116,117],"TCR-T cell therapy","KRAS","Autologous","PDAC","NSCLC","Colorectal Cancer","HLA-C*08:02","HLA-A*11:01","HLA-A*11:02",{"date":84,"type":49},{"date":120,"type":49},"2024-03-22",{"date":122,"type":20},"2043-11-18",{"name":55,"class":56},{"id":125,"slug":4,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":149},"100626472","NCT07436078","Culturally Adapting an Intervention to Increase Genetic Testing in African American Cancer Survivors","A Community-Engaged Approach to Culturally Adapting an Intervention to Increase Uptake of Genetic Testing Among African American Cancer Survivors","Inclusion Criteria:\n\n* Participants enrolled in Detroit Research on Cancer Survivors (Detroit ROCS)\n* Diagnosis of Primary Breast, prostate, or colorectal cancer on or after 1\u002F1\u002F2013\n* have received or currently receiving care at Karmanos Cancer Institute\n* meet one or more of the National Comprehensive Cancer Network (NCCN) guidelines for cancer genetic testing as described below\n\nFemale breast\n\n1. personal diagnosis at age ≤50\n2. personal history of the triple-negative subtype\n3. at least 1 close (first- or second-degree) relative diagnosed with breast cancer at age \\\u003C50\n4. at least 1 close relative diagnosed with ovarian cancer\n5. 2+ close relatives diagnosed with breast or prostate cancer\n6. age \\\u003C50 AND another primary breast cancer at any age\n7. 2+ primary breast cancers at any age\n\nOR Prostate\n\n1. personal history of high-risk or very high-risk prostate cancer\n2. personal history of regional or metastatic prostate cancer\n3. personal history of less than high-risk prostate cancer with a suggestive family history (i.e., father or brother or multiple relatives with prostate cancer diagnosed at age \\\u003C60; at least 1 relative with breast, ovarian, or pancreatic cancer; or at least 1 relative with colorectal, ovarian, pancreatic, or kidney cancer)\n\nOR Colorectal\n\n1. personal diagnosis at age ≤50\n2. at least 1 close relative diagnosed with HNPCC at age \\\u003C50\n3. at least 2 close relatives diagnosed with an HNPCC cancer at any age\n4. colorectal and \\>=1 primary endometrial, ovarian, gastric, pancreatic, or prostate\n\nExclusion Criteria:\n\n* Previous genetic counseling and\u002For testing","20 Years","79 Years",{"count":133,"type":20},85,[69],"The goal of this clinical trial is to culturally adapt an educational genetic counseling intervention to increase the uptake in genetic counseling and testing among African Americans at risk for heredity cancers. With the help of community stakeholders and clinical genetic professionals the investigators will:\n\n* adapt and refine a culturally relevant online educational genetic counseling program for at-risk African Americans\n* Test the effects of the educational program\n* collaborate with community leaders and clinical genetic professionals to translate study findings, develop a road map for dissemination to the community, and identify barriers to prepare for future trials.\n\nParticipants from Detroit Research on Cancer Survivor group will be offered enrollment. Once consent is obtained, questionnaires will be completed before an online genetic counselling intervention immediately after, and at 3 months",[137,138,28],"Female Breast Cancer","Prostate Cancer","2026-06-19",{"date":141,"type":49},"2026-06-23",{"date":143,"type":49},"2026-04-18",{"date":145,"type":20},"2029-07",{"name":147,"class":148},"Barbara Ann Karmanos Cancer Institute","OTHER",1,{"id":151,"slug":4,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":63,"sex":16,"minAge":64,"maxAge":65,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":149},"100579302","NCT06822530","A Multilevel Intervention to Increase Colorectal Cancer Screening Tests in Patients With Abnormal Fecal Immunochemical Test Results, PROACT Trial","PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions","Inclusion Criteria:\n\n* PATIENTS: Age \\>= 45 years old and =\\\u003C 75 years old\n* PATIENTS: Receives care at an Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) or University of Washington- Federal Way (UW-Federal Way) primary care clinic\n* PATIENTS: \\>= 1 month from documented abnormal FIT result\n* PATIENTS: Has not received a colonoscopy between the abnormal FIT and enrollment\n* CLINIC STAFF: HMC, UW-Federal Way, or UW-KDM physician or staff member who provides primary care or gastroenterology care\n* CLINIC STAFF: Staff in the Fred Hutchinson (Fred Hutch)\u002FUW Medicine Population Health Program that provide colorectal cancer screening and navigation",{"count":157,"type":20},682,[69],"This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.",[28],"2026-06-18",{"date":163,"type":49},"2026-06-22",{"date":165,"type":49},"2025-12-16",{"date":167,"type":20},"2030-01-31",{"name":169,"class":148},"Fred Hutchinson Cancer Center",{"id":171,"slug":4,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":180,"conditions":181,"keywords":209,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100499720","NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.",{"count":177,"type":20},554,[23,179],"PHASE2","BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[26,182,183,184,185,186,187,188,189,190,191,192,113,193,194,107,195,196,197,198,199,114,28,200,201,202,203,204,205,206,207,208],"Histiocytic Neoplasm","Histiocytosis","BRAF Gene Mutation","BRAF V600E","BRAF V600 Mutation","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Cancer","Recurrent Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma","Solid Tumor","Solid Carcinoma","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Cancer","Thyroid Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Brain Metastases","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[210,211,212,110,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227],"BRAF Class I","BRAF Class II","BRAF Class III","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions","2026-06-16",{"date":230,"type":49},"2026-06-17",{"date":232,"type":49},"2023-04-18",{"date":234,"type":20},"2028-06",{"name":236,"class":148},"Institut de Recherches Internationales Servier",27,{"id":239,"slug":4,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100487723","NCT05630794","Testing for Safety and Colorectal Cancer Preventive Effects of ONC201","Phase I Trial of ONC201 for Chemoprevention of Colorectal Cancer","Inclusion Criteria:\n\n* Be identified as high risk for recurrent colorectal adenomas, as defined by:\n\n  * A diagnosis of FAP AND\u002FOR\n  * Findings of either \\> 5 small (less than 1 cm) adenomas OR \\>= 3 with at least one \\>= 10 mm on most recent colonoscopy performed in the past 5 years\n* Be \\>= 18 years of age on day of signing informed consent\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 70%)\n* Leukocytes \\>= 3,000\u002Fmicroliter\n* Absolute neutrophil count \\>= 1,000\u002Fmicroliter\n* Platelets \\>= 100,000\u002Fmicroliter\n* Total bilirubin within normal institutional limits\n* Aspartate aminotransferase (AST) (serum (glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (\\[SGPT\\]) =\\\u003C 1.5 x institutional upper limit of normal\n* Creatinine =\\\u003C 1.5 x institutional upper limit of normal\n* Participant is due to undergo a standard of care lower gastrointestinal (GI) colonoscopy for detection and removal of colorectal polyps. On this colonoscopy, participant is required to have:\n\n  * Two (2) adenomatous polyps of at least five (5) mm in size\n  * At least one (1) polyp within reach of a flexible sigmoidoscope (which will be retained in the colon or rectum and marked)\n  * In addition to polypectomy, six (6) biopsies of normal colonic mucosa \\>= 1 cm from a collected polyp will also be collected\n* Willing to undergo a second, research intent endoscopic procedure (either sigmoidoscopy or colonoscopy), approximately 12 weeks after initiating ONC201 treatment\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n* Life expectancy of at least 5-years\n* ONC201 is an imipridone agent with the potential for teratogenic or abortifacient effects. For this reason and because imipridones potential teratogenic effects are unknown, men and women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for four weeks after study treatment is completed. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should STOP the study medication and inform her study physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Prior history of hereditary nonpolyposis colorectal cancer (HNPCC), also known as Lynch syndrome\n* Participants may not be currently receiving any other investigational agents or have received any investigational agents within the past four weeks\n* Prior history of invasive colorectal cancer\n* Prior invasive active neoplasm that is progressing or requires active treatment within 3 years from registration. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Participants with a history of prior invasive neoplasm diagnosed and treated greater than 3 years form registration may be considered with consultation of the primary investigator\n* Prior history of exposure to cytotoxic chemotherapy or ONC201\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC201\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant and women who are nursing are excluded from this study because ONC201 is an imipridone agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with ONC201, breastfeeding should be discontinued if the mother is treated with ONC201\n* Concomitant use of strong\u002Fmoderate CYP3A4\u002F5 inducers\u002Finhibitors. These agents must be discontinued at least 72-hours prior to beginning ONC201\n* Any of the following cardiac criteria:\n\n  * Prolongation of corrected QT (QTc) interval (QTc interval \\> 480 milliseconds, preferably using Frederica's QT correction formula), confirmed on electrocardiogram (ECG) tracings performed during screening\n  * A history of Torsades de pointes, heart failure, or family history of prolonged QT Syndrome\n* Concomitant use of drugs that are known to prolong QT and have a known risk of torsade de pointes (TdP) unless they are willing to stop these medications and possibly change to an alternative non-excluded medication to treat the same condition at least 72 hours prior to beginning ONC201",{"count":245,"type":20},36,[23],"The purpose of this phase I trial is to test the safety and cancer preventive effects of different doses of ONC201 in people with familial adenomatous polyposis (FAP) or a history of multiple polyps. People with familial adenomatous polyposis (FAP) or a history of multiple polyps are at higher than average risk of developing colorectal cancer. ONC201, now known as dordaviprone, is a drug that may stop cancer cells from growing. This drug has been shown in previous studies to cause cancer cell death but not harm normal cells. If successful, this study may help us develop a new option for colorectal cancer prevention.",[249,28,250,251],"Colorectal Adenomatous Polyp","Familial Adenomatous Polyposis","Multiple Adenomatous Polyps","2026-06-11",{"date":254,"type":49},"2026-06-12",{"date":256,"type":49},"2025-10-06",{"date":258,"type":20},"2028-03-01",{"name":90,"class":91},5,{"id":262,"slug":4,"hasResults":11,"nctId":12,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":275,"leadSponsor":276,"locationsCount":57},"100506685","A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Subjects With Unresectable, Advanced and\u002For Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria\n\n* Subjects must be at least 18 years of age, at the time of signing the informed consent.\n* Subjects must be capable of giving signed informed consent.\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele) as confirmed by an CLIA-accredited laboratory-based test.\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion per computed tomography (CT) scan or magnetic resonance imaging (MRI) per RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n* Per Investigator judgement, subject is likely to complete study visits and\u002For procedures per the protocol and comply with study requirements for study participation\n\nKey Exclusion Criteria\n\n* Any another primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or rIL-2; or known sensitivity or allergy to methotrexate, gentamicin, or other aminoglycosides.\n* Any form of primary immunodeficiency.\n* Live vaccine ≤ 4 weeks prior to enrollment or plans to have a live vaccine prior to planned lymphodepleting chemotherapy and\u002For NT-175 treatment.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.",{"count":19,"type":20},[23],"Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.",[26,27,28,29,30,31,32],[35,36,37,38,39,40,41,30,32,44],"2026-06-09",{"date":273,"type":49},"2026-06-10",{"date":51,"type":49},{"date":53,"type":20},{"name":55,"class":56},{"id":278,"slug":4,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":63,"sex":16,"minAge":17,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":149},"100639943","NCT07618273","Smart Symptom Tracking ALEX Application for Tracking and Monitoring Gastrointestinal Health, Smart Horizons Pilot Trial","Smart Horizons Pilot: A Feasibility and Outcomes Evaluation of Digital Symptom Tracking for Gastrointestinal Health","Inclusion Criteria:\n\n* Ages 18-44 years\n* Concerned about their GI health\n* Able to speak and read English\n* Willing to complete a four-week symptom tracking protocol\n\nExclusion Criteria:\n\n* Unable to understand the informed consent or comply with protocol requirements","44 Years",{"count":285,"type":20},50,[69],"This clinical trial compares the impact of the Smart Symptom Tracking ALEX application (app) to standard symptom-tracking practices in tracking and monitoring gastrointestinal (GI) symptoms in young adults. Rates of early-onset colorectal cancer are rising sharply and it is projected to become the leading cause of cancer-related death in young adults. Despite this, adults under 45 still face barriers to diagnosis, including access to screening, unclear guidance on the impact of GI symptoms and dismissal of symptoms by healthcare providers. Current screening guidelines lack guidance on monitoring early symptoms in younger adults. The Smart Symptom Tracking ALEX tool is a digital platform that uses artificial intelligence to provide prompts for symptoms, coaching, reminders and education. Standard of care clinical practices include paper-based logs to report symptoms. Using the Smart Symptom Tracking ALEX app may provide more detailed symptom reports and increase self-reported symptom communication compared to standard symptom-tracking practices in young adults concerned about their GI health.",[28],"2026-06-03",{"date":291,"type":49},"2026-06-05",{"date":293,"type":49},"2026-04-20",{"date":295,"type":20},"2029-04-20",{"name":297,"class":148},"Mayo Clinic",{"id":299,"slug":4,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":21,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100521004","NCT06063928","Confronting Cancer as a Community","Inclusion Criteria:\n\n* Self-reported Hispanic ethnicity\n* Diagnosed with colon or rectal cancer (at any time and stage; lifetime diagnosis and in survival are eligible)\n* Has a tumor tissue sample archived or plans to have tissue archived from a standard care procedure\n* Age \\>= 18 years\n* Ability to understand and the willingness to sign a written informed consent.\n* For those who would like to participate in the optional microbiome characterization aspect of the study, the patient will have to be under 40 years old at any clinical cancer stage or over 60 years old at any clinical cancer stage.\n\nExclusion Criteria:\n\n* Inability to understand and the willingness to sign a written informed consent",{"count":304,"type":20},500,[69],"This study aims to better understand the cause of colorectal cancer and how to find the best treatment for Hispanic patients with colorectal cancer. The genetic information in the blood and tissues may explain why patients who have the same type of cancer and receive the same treatment do not always have the same results. By combining genetic (certain qualities or traits passed from parents to offspring) information with clinical data, such as the responses of different kinds of cancers to different treatments, this study could lead to more knowledge about why certain cancers occur and why they respond differently to treatments. Information gathered from this study may help researchers match treatments to the genetics of each patient and the genetic changes in their tumor. This approach is known as personalized medicine.",[28],"2026-05-29",{"date":310,"type":49},"2026-06-02",{"date":312,"type":49},"2022-05-25",{"date":314,"type":20},"2028-05-25",{"name":316,"class":148},"University of Southern California",2,{"id":319,"slug":4,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":338},"100470831","NCT05410977","Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients","Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study","Inclusion Criteria:\n\n* Patients at least 18 years of age\n* Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or colorectal cancer (CRC) with suspected Lynch syndrome or individuals diagnosed with early onset CRC (\\\u003C55 years old)\n* Colonoscopy\u002Fflexible sigmoidoscopy (flex sig) scheduled +\u002F- 90 days from sample collection\n* Patient has agreed to participate and has signed the study consent form\n\nExclusion Criteria:\n\n* Patient has known cancer (stage I-IV) within 5 years prior to current sample collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)\n* Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current sample collection\n* Patient has had any abdominal radiation therapy prior to current sample collection\n* Patient had therapy to the target (non-hyperplastic) lesion with intent to completely remove or debulk the lesion prior to sample collection \\[examples include snare polypectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), surgical resection, trans anal excision\\]\n* Patient has prior diagnosis of non-lynch hereditary colon cancer syndrome \\[familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, POL\\]\n* ADDITIONAL STOOL EXCLUSIONS:\n* Bowel prep \\\u003C7 days prior to stool collection\n* Oral or rectal contrast given within 7 days prior to stool collection\n* Presence of ileostomy\n* Enteral feeds or total parenteral nutrition (TPN)\n* Diagnosis of inflammatory bowel disease",{"count":325,"type":20},950,"OBSERVATIONAL","This study collects blood and stool samples from patients with suspected or diagnosed Lynch syndrome to evaluate a deoxyribonucleic acid (DNA) screening technique for the detection of colorectal cancer in Lynch syndrome patients.",[28,329],"Lynch Syndrome","2026-05-22",{"date":332,"type":49},"2026-05-27",{"date":334,"type":49},"2022-03-30",{"date":336,"type":20},"2027-12-31",{"name":297,"class":148},9,{"id":340,"slug":4,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":149},"100413679","NCT04666727","Role of Diet on the Microbiome of the Digestive System","The Role of Diet and the Microbiome in Inducing Somatic Mutations in Colorectal Epithelial Cells and Its Predisposition to Carcinogenesis - A Pilot Study","Inclusion Criteria:\n\n* GROUP I: Patients presenting for a screening colonoscopy\n\n  * GROUP I: Age of 45 and above\n  * GROUP I: Strict vegetarian diet, determined by using diet history questionnaire 3.0 National Institutes of Health (NIH)\n  * GROUP I: Non smoker\n  * GROUP I: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood samples\n  * GROUP II: Patients presenting for a screening colonoscopy\n  * GROUP II: Age of 45 and above\n  * GROUP II: Omnivorous diet\n  * GROUP II: Non smoker\n  * GROUP II: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood sample\n\nExclusion Criteria:\n\n* • Current smokers (nicotine abuse only)\n\n  * Positive family history of colon cancer or colon cancer related syndromes\n  * Recent use of antibiotics in 1 month\n  * History of inflammatory bowel disease, and\u002For radiation enteritis or colitis\n  * Pregnant and breastfeeding women\n  * Women of child-bearing potential who have positive urine or serum pregnancy test\n  * Heavy drinker (defined as more than 14 drinks per week)\n  * Currently using anti-flatulence medications, probiotics and\u002For fiber supplements\n  * Major dietary restrictions and\u002For following a special diet\n  * Patient with positive fecal test\u002Fsymptoms",{"count":346,"type":20},30,"This study is to learn more about how diet affects the microbiome (bacteria and microorganisms) of the digestive system. Researchers want to learn if this, in turn, has an effect on if and how people then develop colorectal cancer.",[28],{"date":350,"type":49},"2026-05-26",{"date":352,"type":49},"2020-09-29",{"date":354,"type":20},"2027-01-01",{"name":356,"class":148},"M.D. Anderson Cancer Center",{"id":358,"slug":4,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":21,"phases":365,"briefSummary":367,"conditions":368,"keywords":373,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":149},"100588144","NCT06937567","CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors","Exploratory Study on the Safety and Preliminary Efficacy of UCLH80-1 Cells in Patients With CDH17-Positive Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Histopathologically confirmed malignant solid tumors, including but not limited to colorectal cancer, gastric cancer, pancreatic cancer, and biliary tract tumors.\n* Patients must have failed standard treatments, be intolerant to standard treatments, or lack effective treatment options.\n* At least one measurable lesion as defined by RECIST v1.1 criteria.\n* Tumor tissue must be available either from prior tumor biopsy or by providing new tumor specimens.\n* Tumor specimens must be confirmed as CDH17-positive by immunohistochemistry (IHC) or immunocytochemistry (ICC) staining.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival time ≥ 3 months.\n* Appropriate organ function: hematological: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹\u002FL. Hemoglobin (HGB) ≥ 80 g\u002FL; Platelet count (PLT) ≥ 75 × 10⁹\u002FL. Liver Function: aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3.0 × ULN (≤ 5.0 × ULN for patients with primary liver tumors or liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN for patients with primary liver tumors or liver metastases; ≤ 3 × ULN for Gilbert's syndrome with direct bilirubin ≤ 1.5 × ULN). Coagulation: international normalized ratio (INR) ≤ 1.5 × ULN (unless on therapeutic anticoagulants); activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless on therapeutic anticoagulants). Renal Function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL\u002Fmin (based on Cockcroft-Gault formula). Cardiac Function: left ventricular ejection fraction (LVEF) ≥ 50% (confirmed by echocardiography). Pulmonary Function: resting oxygen saturation (SpO₂) \\> 92% without supplemental oxygen.\n* Female participants of childbearing potential must have a negative pregnancy test.\n* Female participants of childbearing potential or male participants with partners of childbearing potential must agree to use effective contraception during the study and for 1 year after the final cell infusion.\n* Willingness to sign the informed consent form, demonstrating understanding of the study and agreement to comply with study procedures.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding.\n* Positive hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) with peripheral HBV DNA levels above the lower limit of detection.\n* Positive hepatitis C virus (HCV) antibody with peripheral HCV RNA levels above the lower limit of detection.\n* Positive HIV antibody.\n* Positive syphilis-specific and non-specific antibody tests.\n* Non-hematological toxicity from prior treatment (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) has not resolved to ≤ CTCAE grade 1 (except for hair loss and peripheral sensory neuropathy).\n* Prior allogeneic tissue or organ transplant (including bone marrow, stem cell, liver, kidney, etc.), except for transplants not requiring immunosuppression (e.g., corneal or hair transplantation).\n* Patients who have previously received CDH17 CAR-T therapy, except those who received CAR-T infusion within this study.\n* Underwent major surgery within 4 weeks prior to signing informed consent and has not fully recovered, or has a history of serious unresolved trauma.\n* Known central nervous system (CNS) metastases (with exceptions for asymptomatic brain metastases or stable clinical symptoms).\n* Severe active infections or pulmonary diseases requiring systemic corticosteroid treatment within 6 months prior to signing informed consent.\n* Symptomatic congestive heart failure (NYHA class II-IV), severe aortic stenosis, or symptomatic mitral stenosis.\n* ECG showing QTc \\> 450 ms or QTc \\> 480 ms with bundle branch block.\n* Uncontrolled hypertension (SBP ≥ 160 mmHg and\u002For DBP ≥ 100 mmHg).\n* Cerebrovascular accidents within 6 months prior to signing informed consent.\n* Active, chronic, or recurrent severe autoimmune diseases requiring immunosuppressive treatment (with exceptions).\n* Any form of primary or secondary immunodeficiency.\n* Risk of organ perforation or bleeding as judged by the investigator.\n* Severe systemic hypersensitivity reactions to study drugs\u002Fcomponents. - Received live attenuated vaccines within 4 weeks prior to signing informed consent.\n* Participated in another clinical study within 4 weeks prior to signing informed consent.\n* History of another malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer or in situ cancers.\n* Diagnosed with neuropsychiatric disorders or any condition deemed by the investigator as unsuitable for participation.","70 Years",{"count":245,"type":20},[366],"EARLY_PHASE1","The investigational product used in this study, UCLH801 cells, is a CAR-T cell therapy specifically targeting CDH17. The proposed indication includes CDH17-positive advanced solid tumors, such as but not limited to colorectal cancer, gastric cancer, pancreatic cancer, biliary tract tumors, neuroendocrine tumors, ovarian cancer, and lung cancer. The primary objective of this study is to evaluate the safety and tolerability of UCLH801 cells in patients with CDH17-positive advanced malignant solid tumors. The secondary objectives include assessing the preliminary efficacy of UCLH801 cells, their pharmacokinetics and pharmacodynamics in the body, and their immunogenicity.\n\nThis study aims to observe how the infusion of UCLH801 cells affects patients 's body, including any discomfort or changes in laboratory test results. Additionally, it will evaluate whether UCLH801 cells have any effect on tumor. Furthermore, the study will investigate how UCLH801 cells are metabolized; the mechanisms through which they exert their effects, and how to develops any immune response or rejection against UCLH801 cells.",[369,28,370,371,372],"Biliary Tract Cancer","Gastric Cancer, Metastatic","Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)","Multiple Cancer",[374,375],"CAR-T","CDH17","2026-05-20",{"date":350,"type":49},{"date":379,"type":49},"2024-12-26",{"date":381,"type":20},"2028-05-30",{"name":383,"class":148},"Zhejiang University",{"id":385,"slug":4,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":21,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":149},"100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":237,"type":20},[179],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[394,395,396,72,73,397,28,398,399,400,401,402,403,404,405,77,78,406,407,408,409,410,79,80,411,81,412,413,414],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Cervical Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Hodgkin Lymphoma","Mantle Cell Lymphoma","Melanoma","Merkel Cell Carcinoma","Multiple Myeloma","Myelodysplastic Syndrome","Primary Peritoneal Carcinoma","Renal Cell Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma","2026-05-15",{"date":417,"type":49},"2026-05-18",{"date":419,"type":49},"2025-12-18",{"date":421,"type":20},"2026-12-18",{"name":297,"class":148},{"id":424,"slug":4,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":63,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":21,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":149},"100610581","NCT07229443","CoGENES Randomized Controlled Trial (RCT)","Evaluation of a Colorectal Cancer Education Training Program","Inclusion Criteria:\n\n* Must be 18 years of age or older\n* Ability to understand and the willingness to sign a written informed consent\n* Self-reported H\u002FL ethnicity, of any race\n* Ability to read, write, and speak Spanish or English\n* Resides in Los Angeles County\n\nExclusion Criteria:\n\n* Anyone younger than 18 years of age\n* Any person with major cognitive deficit or psychiatric impairment\n* Any person unable to read and write Spanish or English\n* Resides outside of Los Angeles County\n* Any person who considers themselves a community health educator or \"promotor\u002Fa de salud\" and\u002For has taken in the past three years training on colorectal cancer and\u002For cancer genetics",{"count":430,"type":20},140,[69],"This clinical trial evaluates the effectiveness of trained community engagement specialists for improving communication on colorectal cancer (CRC) prevention and genetic testing among Hispanic\u002FLatino\u002Fa\u002Fx (H\u002FL) communities. CRC is the second and third leading cause of cancer deaths among United States (US) H\u002FL men and women respectively. Knowledge of inherited germline mutations (changes in a gene that occurs in a sperm or egg cell) is critical for understanding cause of disease and can impact patient treatment options and outcomes. Educational programs and participant engagement approaches focused on H\u002FL individuals considering Latino cultural values, literacy, numeracy, barriers faced, cultural beliefs and attitudes, as well as language of participants are much needed to address these observed disparities. The Community Genetic Navigation Specialists (CoGENES) Program focuses on increasing knowledge, and preparing the CoGENES trainees to help respond to questions, fears, and concerns regarding genetic testing, counseling, biospecimen (sample of urine, blood, or tissue cells) donation and participation in clinical trials to H\u002FL community members, patients and their families. CoGENES may improve communication on colorectal cancer prevention and genetic testing which can help reduce cancer disparities among H\u002FL communities.",[28],"2026-05-08",{"date":436,"type":49},"2026-05-12",{"date":438,"type":49},"2024-06-20",{"date":440,"type":20},"2027-06-20",{"name":316,"class":148},{"id":443,"slug":4,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":16,"minAge":448,"maxAge":449,"enrollmentInfo":450,"targetDuration":4,"studyType":21,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":482},"100427831","NCT04851119","Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors","A Phase 1\u002F2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors","Inclusion Criteria:\n\n* PART A: Patients must be \\>= 12 months and =\\\u003C 21 years of age at the time of study enrollment\n* PART B: Patients must be \\>= 12 months and =\\\u003C 30 years of age at the time of study enrollment\n* Patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse\n* PART A: Patients with relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors\n* PART B: Patients with recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, and tumors with Wnt pathway aberrations. For the Wnt pathway aberrations cohort we will include the most common CTNNB1 mutations (S37F, S45F, T41A, S45P, S33C, S37C, D32Y, S33F, T41I, G34R, G34V, D32N, S33P, G34E, D32G) as well as any loss of function mutations in the APC, Axin2FBXW7, TCF7L2, and RNF43 genes or any gain-of-function mutations in the GSK3B, LRP6, and LGR5 genes. For patients without prior sequencing, immunohistochemistry (IHC), is required. IHC showing strong nuclear beta-catenin staining will be accepted for the following tumor types: colorectal carcinoma, melanoma, endometrial cancer, ovarian cancer, neuroblastoma, non-Hodgkin lymphoma, pancreatic ductal adenocarcinoma, and solid pseudopapillary tumor of the pancreas\n* PART A: Patients must have either measurable or evaluable disease. For desmoid tumors, the patient must have disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk\u002Fbenefit to the patient to participate in the trial\n* PART B: Patients must have measurable disease. For desmoid tumors, the patient must have measurable disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk\u002Fbenefit to the patient to participate in the trial\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\n\n    * Solid tumor patients: \\>= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n    * Non-Hodgkin lymphoma patients\n\n      * A waiting period prior to enrollment is not required for patients receiving standard maintenance chemotherapy (i.e., corticosteroid, vincristine, thioguanine \\[6MP\\], and\u002For methotrexate)\n      * \\>= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy\n      * NOTE: Cytoreduction with hydroxyurea must be discontinued \\>= 24 hours prior to the start of protocol therapy\n  * Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil counts \\[ANC\\]): \\>= 7 days after the last dose of agent\n  * Antibodies: \\>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\\u003C 1\n  * Corticosteroids: If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n  * Hematopoietic growth factors: \\>= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \\>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total-body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \\>= 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: \\>= 42 days.\n  * Cellular therapy: \\>= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.).\n  * External beam radiation therapy (XRT)\u002Fexternal beam irradiation including protons: \\>= 14 days after local XRT; \\>= 150 days after TBI, craniospinal XRT or if radiation to \\>= 50% of the pelvis; \\>= 42 days if other substantial bone marrow (BM) radiation\n  * Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 \\[131I MIBG\\]): \\>= 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior exposure to tegavivint\n* PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Platelet count \\>= 100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Hemoglobin \\>= 8.0 g\u002FdL at baseline (may receive red blood cell \\[RBC\\] transfusions) (within 7 days prior to enrollment)\n* Patients with known bone marrow metastatic disease will be eligible for study provided they meet blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled on Part A must be evaluable for hematologic toxicity\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a creatinine based on age\u002Fgender as follows (within 7 days prior to enrollment):\n\n  * Age; maximum serum creatinine\n  * Age 1 to \\\u003C 2 years; 0.6 mg\u002FdL (male); 0.6 mg\u002FdL (female)\n  * Age 2 to \\\u003C 6 years; 0.8 mg\u002FdL (male); 0.8 mg\u002FdL (female)\n  * Age 6 to \\\u003C 10 years; 1 mg\u002FdL (male); 1 mg\u002FdL (female)\n  * Age 10 to \\\u003C 13 years; 1.2 mg\u002FdL (male); 1.2 mg\u002FdL (female)\n  * Age 13 to \\\u003C 16 years; 1.5 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n  * Age \\>= 16 years; 1.7 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n* PATIENTS WITH SOLID TUMORS: Bilirubin (sum of conjugated + unconjugated or total) =\\\u003C 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS: Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS: Albumin \\>= 2 g\u002FdL (within 7 days prior to enrollment)\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to the 1st dose of tegavivint to the end of the study\n* Patients who have received bisphosphonates within 4 weeks prior to study enrollment will be excluded\n* Patients who have received denosumab within 180 days prior to study enrollment will be excluded\n* Patients with primary brain tumors are ineligible\n* Patients with known central nervous system (CNS) metastasis, except for craniopharyngeal tumors, will be excluded\n* Patients with a known metabolic bone disease (ex: hyperparathyroidism, Paget's disease, osteomalacia) are not eligible\n* Patients with a disorder associated with abnormal bone metabolism will be excluded\n* Patients with grade \\>= 2 hypocalcemia that is not corrected with oral calcium supplementation will be excluded\n* Patients with vitamin D \\\u003C 20 ng\u002FmL will require supplementation, or will otherwise be excluded. Patients must agree to take vitamin D +\u002F- calcium supplements (if necessary) according to institutional or published guidelines. Additional calcium supplementation is not required if adequate dietary intake can be ascertained\n* Patients with pre-existing grade 3 osteoporosis are excluded\n* Patients who have an uncontrolled infection are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible","12 Months","30 Years",{"count":451,"type":20},147,[23,179],"This phase I\u002FII trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating patients with solid tumors that has come back (recurrent) or does not respond to treatment (refractory). Tegavivint interferes with the binding of beta-catenin to TBL1, which may help stop the growth of tumor cells by blocking the signals passed from one molecule to another inside a cell that tell a cell to grow.",[28,398,407,455,79,104,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471],"Neuroblastoma","Recurrent Desmoid Fibromatosis","Recurrent Ewing Sarcoma","Recurrent Hepatoblastoma","Recurrent Hepatocellular Carcinoma","Recurrent Malignant Solid Neoplasm","Recurrent Non-Hodgkin Lymphoma","Recurrent Osteosarcoma","Refractory Desmoid Fibromatosis","Refractory Ewing Sarcoma","Refractory Hepatoblastoma","Refractory Hepatocellular Carcinoma","Refractory Malignant Solid Neoplasm","Refractory Non-Hodgkin Lymphoma","Refractory Osteosarcoma","Solid Pseudopapillary Neoplasm of the Pancreas","Wilms Tumor","2026-05-01",{"date":474,"type":49},"2026-05-05",{"date":476,"type":49},"2021-11-08",{"date":478,"type":20},"2028-06-30",{"name":480,"class":481},"Children's Oncology Group","NETWORK",21,{"id":484,"slug":4,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":21,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":506},"100571667","NCT06723236","A Study of MGC028 in Participants With Advanced Solid Tumors","A Phase 1, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants in dose escalation or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma (CRC), or pancreatic carcinoma that is refractory to standard therapy, or for which standard therapy does not exist, has proven to be intolerable, or has been refused by the participant.\n* Participants in expansion cohorts must have either\n\n  * NSCLC adenocarcinoma with\n\n    * progression on or following anti-PD-1\u002FPD-L1 inhibitor, unless contraindicated\n    * progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present\n    * no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.\n  * Pancreatic cancer\n\n    * following at least 1 systemic therapy\n    * no more than 2 prior lines of cytotoxic therapy for advanced or metastatic disease.\n  * Colorectal adenocarcinoma with\n\n    * Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable\n    * Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI- H\u002FdMMR, if present.\n    * No more that 2 lines of cytotoxic chemotherapy for advanced or metastatic disease\n    * No more than 4 lines of systemic regimens for advanced or metastatic disease\n* Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.\n* Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.\n* Participants have acceptable physical condition and laboratory values.\n* Participants of childbearing potential must agree to use highly effective methods of birth control.\n* Participants must not be pregnant, planning to be pregnant, or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Active brain metastases or leptomeningeal metastases.\n* Prior stem cell, tissue, or solid organ transplant.\n* Another malignancy that required treatment within the past 2 years, with the exception of those with a negligible risk of metastasis or death such as adequately treated non-melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Active viral, bacterial, or fungal infection\n* Prior treatment with ADAM9 targeted agent for cancer.\n* Prior treatment with major surgery, mediastinal or lung radiation, vaccination with live virus vaccines, systemic cancer treatment, chimeric antigen receptor (CAR)-T cell therapy, or experimental treatment within 4 weeks of the start of study treatment.",{"count":490,"type":20},124,[23],"The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9.\n\nThe main question the study aims to answer is:\n\n* What types of side effects will participants experience when receiving MGC028?\n* Can MGC028 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors?\n\nParticipants will\n\n* Undergo screening procedures to determine eligibility\n* Receive study treatments initially every 3 weeks.\n* Have blood samples taken for routine and research tests\n* Have other examinations to check heart and lung function, and general health status\n* Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary.\n* Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.",[494,495,496,80,28],"Advanced Solid Tumors","NSCLC Adenocarcinoma","Cholangiocarcinoma","2026-04-23",{"date":499,"type":49},"2026-04-27",{"date":501,"type":49},"2025-02-13",{"date":503,"type":20},"2027-04",{"name":505,"class":56},"MacroGenics",7,{"id":508,"slug":4,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":21,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":537},"100624118","NCT07405476","Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment","A Phase II Clinical Trial of Neoadjuvant Zanidatamab for HER2+ Localized Colorectal Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed colon and\u002For rectal cancer planned for curative intent treatment at gastrointestinal clinics of Emory University's Winship Cancer Institute and collaborating centers\n* Tumors must be HER2+ve (human epidermal growth factor receptor 2 \\[HER2\\] overexpression 3+ immunohistochemistry \\[IHC\\] or 2+ by IHC and positive fluorescence in situ hybridization \\[FISH\\] or HER2 amplification by next generation sequencing)\n* Tumors must have RAS wildtype genotype\n* Radiologically measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)\n* Platelet count \\> 100,000 cells\u002F ul (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Hemoglobin \\> 9g\u002Fdl (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Absolute neutrophil count \\> 1000 cells\u002Fdl (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Alanine aminotransferase (ALT) ≤ 3 × ULN (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Total bilirubin ≤ 1.5 × ULN, or ≤ 3 × ULN for participants with Gilbert's disease (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Glomerular filtration rate (GFR) \\> 60ml\u002Fmin (based on creatine, and Cystatin C estimation where applicable) (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Adequate cardiac function with left ventricular ejection fraction of at least 50% (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy\n* FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 3 months after completion of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\n  \\* A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. This includes willingness to undergo mandatory blood sample draws for evaluation of correlatives\n* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n* Participants with stage IV colon and rectal cancer even if curative intent resection is planned\n* HER2 expression that does not meet documented inclusion criteria\n* RAS mutation\n* MSI-H or mismatch repair deficient rectal cancer\n* Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF). Participants with known myocardial infarction or unstable angina within 6 months prior to expected date of cycle 1 day 1 (C1D1) are also excluded. Previous anticancer therapy-related CHF must have been ≤ grade 1 at the time of occurrence and must have completely resolved\n* Participants receiving any other investigational agents or an investigational device within 28 days of administering the first dose of study drug\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study\n* Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":92,"type":20},[179],"This phase II trial studies how well giving zanidatamab before surgery (neoadjuvant) works in treating patients with colon and rectal cancer that is human epidermal growth factor receptor 2 positive (HER2+ve) who are planned for curative intent treatment. Zanidatamab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).",[517,28,518,519,520,521,522,523,524,525,526,527],"Colon Carcinoma","Rectal Carcinoma","Stage I Colon Cancer AJCC v8","Stage I Colorectal Cancer AJCC v8","Stage I Rectal Cancer AJCC v8","Stage II Colon Cancer AJCC v8","Stage II Colorectal Cancer AJCC v8","Stage II Rectal Cancer AJCC v8","Stage III Colon Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8","2026-04-16",{"date":530,"type":49},"2026-04-17",{"date":532,"type":49},"2026-04-07",{"date":534,"type":20},"2029-12-18",{"name":536,"class":148},"Emory University",4,{"id":539,"slug":4,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":363,"enrollmentInfo":544,"targetDuration":4,"studyType":21,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":149},"100510750","NCT05930496","Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors","A Randomized Controlled Trial Testing the Effects of an Exercise Intervention on the Gut Microbiota in Colorectal Cancer Survivors: A Pilot and Feasibility Study","Inclusion Criteria:\n\n* 18-70 years of age\n* Previous diagnosis of stage II-III CRC cancer\n* No known current, recurrent, or metastatic disease\n* No comorbid or physical limitations that would limit participation at the discretion of the treating provider\n* At least 60 days to 3 years from last cancer-directed treatment (including surgery, chemotherapy, and radiation. Elective surgery, including ileostomy reversal, is not counted in this timing but patients must be able to eat a normal diet, without post-operative dietary limitations)\n* Body mass index (BMI) 18.5-35 kg\u002Fm\\^2\n* Able to understand and willing to sign written informed consent in English\n* Access to phone for study contacts\n* Access to a smart phone or tablet to connect to the Polar H10 Heart rate sensor during remote exercise sessions and attend virtual exercise sessions\n* Be willing and able to attend up to 24 sessions in-person at the Fred Hutch Exercise Research Center Shared Resource or virtually via phone, Zoom, or Microsoft Teams, based on participant preference\n* Access to internet (internet access may be provided on a case-by-case basis to participants where access to internet would otherwise be the only barrier to participation)\n* Willingness to participate in all study activities\n* Completion of all run-in activities\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status score of 0 or 1 for performance status\n* Women must not be pregnant, breastfeeding, or planning to become pregnant\n\nExclusion Criteria:\n\n* Use of oral or intravenous antibiotics, antifungals, or antiparasitics during the past 6 months\n* Presence of an ileostomy or colostomy because of known changes to the gut microbiome with ileostomies and colostomies\n* Current status of underweight (BMI \\\u003C 18.5 kg\u002Fm\\^2) or class II\u002FIII obesity (BMI ≥ 35.0 kg\u002Fm\\^2)\n* Presence of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis as these are known to baseline have differences in gut microbiome composition\n* Women who are pregnant, breastfeeding, or planning to become pregnant\n* Physician notification to not approach patient for the study",{"count":346,"type":20},[69],"This trial evaluates the effects a moderate-to-vigorous exercise intervention has on the bacterial make-up of the gastrointestinal tract (gut microbiota) in survivors of stage II-III colorectal cancer (CRC). Data shows that the gut microbiota composition and function may be drivers of CRC. High levels of exercise are associated with improved CRC prognosis and survival. While data suggests that exercise has the potential to influence gut microbiota composition and function, it is not known whether these effects contribute to improved CRC prognosis. This clinical trial evaluates the effects an exercise intervention has on gut microbiota and how these effects relate to CRC progression and patient-reported outcomes.",[523,526,28],"2026-04-15",{"date":293,"type":49},{"date":551,"type":49},"2025-07-08",{"date":553,"type":20},"2027-07-01",{"name":169,"class":148},{"id":556,"slug":4,"hasResults":11,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":63,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":21,"phases":563,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":149},"100473671","NCT05447923","Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities","Colorectal Cancer Screening in Black and Underserved Communities in the Phoenix Metro Area: Addressing Disparities in Cancer Prevention","Inclusion Criteria:\n\n* Age 45 years of age or older\n* No prior history of colorectal cancer or colon polyps\n* No first-degree family history of colorectal cancer who were diagnosed under age 60\n* No current gastrointestinal (GI) or rectal symptoms (such as rectal bleeding)\n* Have not undergone a colonoscopy in the last 5 years\n* Have not had a fecal immunochemical test (FIT) test within the last year\n* Participants that attend 4 predominantly African American churches within the Phoenix Community and extend the study opportunity as feasible to other underserved communities in the Phoenix Metro area",{"count":562,"type":20},450,[69],"This clinical trial studies disparities involving colorectal cancer prevention and screening in Black and underserved communities in the Phoenix metropolitan area. The Black community is disproportionately impacted by colorectal cancer, with the highest rate of any racial\u002Fethnic group in the United States. There are complex reasons behind these disparities, largely related to socioeconomic factors and healthcare access. Providing access to free, home-based fecal immunochemical testing (FIT), colorectal screening education, and appropriate follow-up to predominantly Black community-based organizations and underserved communities may help to close this gap.",[28],"2026-04-01",{"date":568,"type":49},"2026-04-02",{"date":570,"type":49},"2022-05-22",{"date":572,"type":20},"2030-06-01",{"name":297,"class":148},{"id":575,"slug":4,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":583,"conditions":584,"keywords":586,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":506},"100424900","NCT04812912","Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer","The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients","Inclusion Criteria:\n\n* 18-40 years of age and premenopausal (female) or 18-50 years of age (male) at time of diagnosis\n* Histologic diagnosis of colorectal adenocarcinoma\n* Able and willing to participate in the informed consent process\n* Eligible for curative adjuvant or neoadjuvant therapy for colon or rectal cancer\n* Willing and able to complete protocol questionnaires\n* Rectal patients only: Individuals who will be receiving chemotherapy, followed by chemoradiotherapy (ChemoRT)\n\nExclusion Criteria:\n\n* Prior systemic treatment for this malignancy\n* Active or prior secondary malignancy\n* History of ovarian resection (if female)\n* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception until the termination of gestation, confirmed by a positive hCG laboratory test.","50 Years",{"count":582,"type":20},120,"The purpose of this study is to find out how cancer treatments (chemotherapy and\u002For radiation therapy) affect reproductive and sexual health in people with early onset colorectal cancer. The study researchers will observe and track changes in hormone levels and in sexual and reproductive health in people with early onset colorectal cancer. This information will help researchers know more about how cancer treatments affect reproductive and sexual health, including the ability to have children (fertility).",[114,585,28],"Colorectal Neoplasms",[587,114,588,589],"Early Onset Colorectal Cancer","21-035","Memorial Sloan Kettering Cancer Center",{"date":532,"type":49},{"date":592,"type":49},"2021-03-18",{"date":594,"type":20},"2027-03-18",{"name":589,"class":148},{"id":597,"slug":4,"hasResults":11,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":65,"enrollmentInfo":602,"targetDuration":4,"studyType":21,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":149},"100581422","NCT06850103","SCRT-CAPEOX-Serplulimab for MSS\u002FpMMR Rectal Cancer With Oligometastases","A Phase II Exploratory Multicenter Randomized Controlled Clinical Trial to Evaluate the Effectiveness of Neoadjuvant Short-Course Radiotherapy (SCRT) Followed by CAPEOX Chemotherapy and Serplulimab in Microsatellite Stable (MSS) or Proficient Mismatch Repair (pMMR) Rectal Cancer With Synchronous Oligometastases","Inclusion Criteria:\n\n\\- Has signed the written Informed Consent Form (ICF) and is able to comply with protocol-specified visits and procedures.\n\nAge between 18-75 years.\n\nHistologically confirmed primary rectal adenocarcinoma, with MRI showing tumor location within 10cm from the anal verge.\n\nSynchronous oligometastatic rectal cancer confirmed by comprehensive imaging evaluation (contrast-enhanced CT, contrast-enhanced MRI, PET-CT, etc.), with ≤2 metastatic sites and ≤5 total metastatic lesions.\n\nMicrosatellite stability status confirmed as MSS (using the NCI-recommended 5 microsatellite markers: BAT25, BAT26, D5S346, D2S123, D17S250) or proficient mismatch repair (pMMR) status confirmed by immunohistochemistry showing positive nuclear expression of all 4 MMR proteins (MLH1, MSH2, MSH6, PMS2).\n\nAt least one measurable lesion according to RECIST v1.1 criteria.\n\nEastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.\n\nAdequate organ function and bone marrow reserve, defined as follows:\n\nComplete blood count:\n\nAbsolute Neutrophil Count (ANC) ≥1.5×109\u002FL Platelet count (PLT) ≥100×109\u002FL Hemoglobin (HGB) ≥10.0g\u002FdL\n\nLiver function:\n\nTotal Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (ULN) Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤3×ULN Serum albumin (ALB) ≥35 g\u002FL\n\nRenal function:\n\nSerum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin (calculated using Cockcroft-Gault formula \\[see Appendix 3\\] or standard 24-hour urine collection method) Urine protein by dipstick \\\u003C2+ For subjects with baseline urine protein ≥2+ by dipstick, 24-hour urine protein must be \\\u003C1g\n\nCoagulation:\n\nInternational Normalized Ratio (INR) ≤1.5 Activated partial thromboplastin time (APTT) ≤1.5×ULN Certain anticoagulant medications (such as antiplatelet agents, vitamin K antagonists) must be discontinued 7-14 days before surgery and replaced with alternative medications (such as low molecular weight heparin) No concurrent serious diseases that would threaten subject survival (leading to expected survival \\\u003C5 years).\n\nWomen of childbearing potential and men whose partners are of childbearing potential must use effective contraception during the entire treatment period and for 6 months after treatment completion. Female subjects must either have evidence of post-menopausal status, or if pre-menopausal, have a negative urine or serum pregnancy test.\n\nExclusion Criteria:\n\n\\- More than 2 metastatic sites or more than 5 total metastatic lesions confirmed by imaging evaluation.\n\nPrior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n\nPrevious treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), or adoptive cell immunotherapy.\n\nConcurrent participation in another clinical trial, except for observational (non-interventional) studies or survival follow-up phase of interventional studies.\n\nReceipt of any investigational drug within 4 weeks prior to first dose of study drug.\n\nHistory of blood transfusion or use of G-CSF, GM-CSF, EPO, TPO, or IL-11 within 14 days prior to screening laboratory tests.\n\nUse of immunosuppressive medications within 4 weeks prior to first dose of study drug, excluding:\n\nIntranasal inhaled corticosteroids or local steroid injections Systemic corticosteroids at ≤10 mg\u002Fday prednisone equivalent Corticosteroids as premedication for allergic reactions (e.g., CT contrast) Traditional Chinese medicines with anti-tumor indications or immunomodulatory effects within 1 week prior to first dose Receipt of live or attenuated vaccines within 4 weeks prior to first dose or anticipated during the study period.\n\nMajor surgery within 4 weeks prior to first dose (e.g., craniotomy, thoracotomy, or laparotomy), anticipated major surgery during treatment (excluding protocol-specified rectal cancer surgery), or presence of unhealed wounds, ulcers, or fractures.\n\nKnown active or suspected autoimmune disease or history within past 2 years (exceptions: eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in past 2 years; hypothyroidism requiring only hormone replacement; Type I diabetes requiring only insulin).\n\nKnown history of primary immunodeficiency.\n\nActive tuberculosis, current anti-TB treatment, or anti-TB treatment within 1 year prior to first dose.\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\nKnown allergy to capecitabine, oxaliplatin, serplulimab, or other monoclonal antibody components.\n\nClinically significant ascites, pleural effusion requiring intervention, or symptomatic pericardial effusion requiring drainage.\n\nHIV infection (HIV antibody positive).\n\nAcute or chronic active hepatitis B (defined as HBsAg positive or HBcAb positive only with HBV DNA ≥2000 IU\u002FmL or ≥1×104 copies\u002FmL) or hepatitis C (defined as HCV antibody positive with detectable HCV RNA).\n\nActive syphilis infection requiring treatment.\n\nSevere infection within 4 weeks prior to first dose, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; therapeutic oral or IV antibiotics within two weeks prior to first dose.\n\nSymptomatic congestive heart failure (NYHA class II-IV) or LVEF \\\u003C50%; symptomatic or uncontrolled arrhythmias; congenital long QT syndrome or QTc \\>500 ms at screening (Fridericia's formula).\n\nUncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) despite standard therapy, history of hypertensive crisis or encephalopathy.\n\nSevere bleeding diathesis or coagulation disorders, or current thrombolytic therapy.\n\nAny arterial thromboembolic events within 6 months prior to first dose, including myocardial infarction, unstable angina, stroke, or TIA.\n\nEsophageal or gastric varices requiring immediate intervention; high bleeding risk subjects require endoscopic evaluation within 3 months before enrollment.\n\nHistory of GI perforation and\u002For fistula within 6 months prior to first dose.\n\nLife-threatening bleeding event within 3 months prior to first dose, or Grade 3\u002F4 GI\u002Fvariceal bleeding requiring transfusion, endoscopy, or surgery.\n\nHistory of DVT, PE, or other serious thromboembolism within 3 months prior to first dose (excluding catheter-related thrombosis or superficial thrombosis).\n\nUncontrolled metabolic disorders or other non-malignant conditions causing high medical risk or uncertain survival evaluation.\n\nHepatic encephalopathy, hepatorenal syndrome, or Child-Pugh B \\>7 or worse cirrhosis.\n\nBowel obstruction (including incomplete requiring parenteral nutrition); conditions with perforation risk; history of extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.\n\nInterstitial lung disease requiring treatment; history of pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, organizing pneumonia, or severe pulmonary dysfunction.\n\nSignificant malnutrition (5% weight loss within 1 month or 15% within 3 months of consent, or \\>50% reduced intake for 1 week), unless corrected for ≥4 weeks before first dose.\n\nHistory of other primary malignancies, except:\n\nCured malignancies with ≥2 years disease-free and low recurrence risk Well-treated non-melanoma skin cancer or lentigo maligna Well-treated carcinoma in situ\n\nOther acute or chronic conditions that could:\n\nIncrease study participation risks Interfere with result interpretation Make subject unsuitable per investigator judgment Neurological, psychiatric, or social conditions affecting compliance or safety assessment.\n\nAlcohol, drug, or substance abuse affecting drug administration or toxicity analysis.\n\nPregnant or breastfeeding women.\n\nConditions interfering with medication management or toxicity analysis due to alcohol, drug, or substance use.\n\nPregnancy or breastfeeding.",{"count":603,"type":20},51,[179],"Background and Significance:\n\nColorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs.\n\nCurrent Treatment Landscape:\n\nThe management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) status. The ESMO guidelines officially categorized metastatic CRC into oligometastatic and widespread metastatic states in 2016, emphasizing the importance of integrated local and systemic treatments for oligometastatic colorectal liver metastases (CRLM).\n\nTreatment Evolution and Challenges:\n\nWhile the EPOC study established CAPEOX neoadjuvant chemotherapy followed by R0 resection as the standard treatment for initially resectable CRLM, patients with synchronous rectal cancer oligometastases present unique challenges due to complex local anatomy and high local recurrence risks. Although various neoadjuvant approaches, including Total Neoadjuvant Therapy (TNT), have been studied, they have not demonstrated significant long-term survival benefits, primarily because distant metastases impact survival more significantly than local recurrence.\n\nInnovative Approach:\n\nRecent success with Immunotherapy-Based Total Neoadjuvant Therapy (iTNT) in microsatellite stable\u002Fproficient mismatch repair (MSS\u002FpMMR) locally advanced rectal cancer has shown promising results. Short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy has demonstrated superior efficacy trends, attributed to radiation's immune-activating effects on both local and distant tumor microenvironments.\n\nResearch Objective:\n\nThis project aims to evaluate the effectiveness of iTNT combined with SCRT in MSS\u002FpMMR rectal cancer patients with synchronous oligometastases. The novel approach integrates SCRT with CAPEOX chemotherapy and Serplulimab, potentially improving complete response rates, organ preservation opportunities, and overall treatment efficacy while reducing recurrence risks. This pioneering study represents the first investigation of iTNT in synchronous rectal cancer oligometastases, offering a potentially transformative treatment strategy for this challenging patient population.\n\nResearch Innovation:\n\nThe study uniquely combines SCRT, CAPEOX chemotherapy, and Serplulimab in a neoadjuvant setting for MSS\u002FpMMR synchronous rectal cancer oligometastases, addressing an unmet clinical need and potentially establishing a new treatment paradigm in this field.",[28,607,608,609,610],"Oligometastases","pMMR","MSS","iTNT","2026-03-22",{"date":613,"type":49},"2026-03-25",{"date":615,"type":49},"2025-04-22",{"date":617,"type":20},"2032-12",{"name":619,"class":148},"First Affiliated Hospital of Zhejiang University",{"id":621,"slug":4,"hasResults":11,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":21,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":640},"100583931","NCT06882746","A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas","A Phase I, Open-label, Non-randomised, Multi-center Dose Escalation Trial of BI 765049 Administered by Parenteral Route in Patients With Advanced, Unresectable, and\u002For Metastatic Colorectal Carcinoma (CRC), Gastric Carcinoma (GC), or Pancreatic Ductal Adenocarcinoma (PDAC) to Determine the MTD and the RP2D and to Determine the Dosing Regimen for Further Development of BI 765049","Inclusion criteria:\n\n* For all patients, signed and dated informed consent form (ICF)2\u002Fmain ICF describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.\n* Patient must be ≥18 years of age and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature on the ICFs (ICF1\u002Fscreening ICF and ICF2\u002Fmain ICF).\n* In US: Patients with a histologically or cytologically confirmed diagnosis of colorectal carcinoma (CRC), gastric carcinoma (GC), or pancreatic ductal adenocarcinoma (PDAC).\n* In Europe: Patients with a histologically or cytologically confirmed diagnosis of CRC.\n* Patients with advanced, unresectable, and\u002For metastatic disease. Further inclusion criteria apply.\n\nExclusion criteria:\n\n* Patient with a history of a major surgery within 28 days prior to first dose of BI 765049 (major according to the Investigator's and\u002For Medical Monitor's assessment).\n* Previous or concomitant malignancies other than the one treated in this trial within the last 5 years except:\n\n  * Effectively treated non-melanoma skin cancers\n  * Effectively treated carcinoma in situ of the cervix\n  * Effectively treated ductal carcinoma in situ\n  * Other effectively treated malignancy that is considered cured by local treatment\"\n* Patient with known leptomeningeal disease or spinal cord compression due to disease.\n* Patient requiring anticoagulant treatment which cannot be safely interrupted, if medically needed based on the opinion of the Investigator.\n\nFurther exclusion criteria apply.",{"count":627,"type":20},135,[23],"This study is open to adults with advanced cancer of the colon, rectum, stomach, or pancreas, that is the cancer cannot be removed by surgery or has spread. People can take part in this study if their previous treatment was not successful, or no other treatment exists.\n\nThe study aims to find the highest dose for the study medicine called BI 765049 that people with advanced cancer can tolerate. Another purpose is to find the most suitable dose and best way of administration of BI 765049 for further clinical development. BI 765049 may help the immune system fight cancer.\n\nParticipants receive BI 765049 at least once every 3 weeks. Participants may continue to get BI 765049 treatment as long as they benefit from treatment and can tolerate it. Participants in this study also get additional medication before and after treatment with BI 765049 for better tolerability. If participants take this medication at home, they have daily phone visits.\n\nParticipants regularly visit the study site. The study visits include several overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. Unwanted effects are any health problems that the doctors think were caused by the study medicine or treatment. To find the highest dose of BI 765049 that participants can tolerate, researchers look at the number of participants with certain severe health problems. These are severe health problems that happen within the time from when a person first receives the intended target dose, until one week after they receive it for the second time.",[28,75,104],"2026-03-16",{"date":633,"type":49},"2026-03-17",{"date":635,"type":49},"2025-03-28",{"date":637,"type":20},"2027-05-12",{"name":639,"class":56},"Boehringer Ingelheim",3,{"id":642,"slug":4,"hasResults":11,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":646,"eligibilityCriteria":647,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":661},"100548223","NCT06418204","Assessing Benefits and Harms of Cannabis\u002FCannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics","Complementary Options for Symptom Management In Cancer (COSMIC): Assessing Benefits and Harms of Cannabis and Cannabinoid Use Among a Cohort of Cancer Patients Treated in Community Oncology Clinics","COSMIC","Inclusion Criteria:\n\n* Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer (e.g. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous cell carcinoma, and not otherwise specified).\n* Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and\u002For immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment.\n* Participants must be able to comprehend English or Spanish (for survey completion).\n* Participants must have a working email address and be must be willing to complete surveys online. This can be completed at home, in the clinic or other location.\n* Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment.\n* Participant must reside in the United States, officially determined per patient report on Self-reported Screening Survey\n* In the treating provider's opinion, the participant should have a life expectancy of \\>=6 months. Participants in hospice are not eligible.\n\nOptional Sub-study (available at select sites only):\n\n* Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU).\n* Must be receiving treatment at the WF CCC and VCU.\n* Must be diagnosed with non-small cell lung cancer.\n* Must be planning to receive paclitaxel as part of their chemotherapy in conjunction with Immune Checkpoint Inhibitor (ICIs) PD-1, PD-L1 or CTLA-4.\n\nExclusion Criteria:\n\n* Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.\n* Participants with known pregnancy.\n* Participant received systemic therapy treatment for prior cancer(s) including chemotherapy, immunotherapy, targeted therapy, and hormonal therapy.\n* Participants enrolled in hospice.\n\nOptional Substudy (available at select sites only):\n\n* Participants with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). The use of glucocorticoids as pre-medications for chemotherapy treatment is allowed.\n* Participants with a history of HIV, hepatitis B or hepatitis C.",{"count":649,"type":20},2000,"This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and\u002For (immune checkpoint inhibitors) ICIs.",[73,28,652,407,653],"Lung Non-Small Cell Carcinoma","Non-Hodgkin Lymphoma",{"date":633,"type":49},{"date":656,"type":49},"2025-01-30",{"date":658,"type":20},"2028-08-01",{"name":660,"class":148},"Wake Forest University Health Sciences",467,{"id":663,"slug":4,"hasResults":11,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":63,"sex":16,"minAge":64,"maxAge":65,"enrollmentInfo":669,"targetDuration":4,"studyType":21,"phases":671,"briefSummary":672,"conditions":673,"keywords":674,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":149},"100568547","NCT06682650","Implementation of a ColoRectal Cancer Screening Tool in US Primary Care Practices - Usual Quality Improvement (10 Clinics) vs Normalization Process Theory-Participatory Learning in Action (10 Clinics)","PB-iCRC: Multi-site Practice-Based Implementation of a ColoRectal Cancer Screening Intervention","(PB-iCRC)","Inclusion Criteria:\n\nClinics participating in the DARTNet Institute \u002FAAFP-affiliated NRN clinic serving communities in which at least 25% of the population prefers Spanish-language.\n\nClinic implementation teams Patients participating in implementation teams for whom Spanish is their preferred language, who are bilingual in English and Spanish, Clinics Staff will be included who have any contact regarding CRC screening with patients eligible for screening.\n\nPatients whose CRC screening outcomes will be monitored:\n\nadults 45 to 75 years of age who are due for CRC screening, i.e. who have not received a high-sensitivity fecal occult blood test or a fecal immunochemical test within the past year, fecal DNA testing within 3 years, sigmoidoscopy or barium enema within 5 years, or colonoscopy within 10 years; and who receive primary care at least annually from the site.\n\nExclusion Criteria:\n\n* patients ineligible for routine screening based on a personal or close family history of colorectal cancer or who have increased genetic risk of colon cancer.\n* cognitive or decisional incapacity will be excluded from the implementation teams, after completion of a brief, validate screening tool, the Mini-Cog Exam.",{"count":670,"type":20},2200,[69],"Although implementation intentions (I2)-based tools enhance colorectal cancer (CRC) screening uptake, prior studies have not tested their implementation into routine primary care delivery. In this study, investigators will conduct a cluster-randomized trial in 20 US primary care clinics. Specific aims for the project will be: 1) to test whether a Normalization Process Theory-informed Participatory Learning in Action (NPT-PLA intervention) implementation of a proven implementation Intentions-based colorectal cancer screening tool (\"I2\") improves screening uptake (i.e. screening order and completion) within 6 months of patient enrollment versus usual quality improvement (control) implementation; and 2) to evaluate the facilitators and barriers of each implementation arm using the 2022 expanded Normalization Process Theory (NPT) framework. Multi-disciplinary clinic 'implementation teams' that include clinic staff and patients whose preferred language is Spanish will meet monthly during the first 6 months of clinic participation and aim to integrate into routine primary care the \"I2\" CRC screening tool, using the NPT-PLA intervention or control approach. The I2 tool addresses the \"when,\" \"where\" and \"how\" details of stool sample or colonoscopy screening. The I2 tool will be delivered via an on-line survey or (if patients prefer) by paper form customized for use in English or Spanish. At least 100 patients in each clinic will be enrolled in the first 6 months of clinic participation (2000 in total). All patients eligible for CRC screening will be offered the I2 tool. Their choices will be communicated automatically to clinics for order entry. Primary (Aim 1) outcomes will be CRC screening orders placed (by clinic staff); completion of the I2 tool and CRC screening completion (by patients) over 6 months of patient follow-up. For Aim 2, surveys based on the NPT domains (the \"NOMAD\") will be used to assess staff comprehension of their role in implementing the I2-based CRC screening tool, its salience, their buy-in, feasibility of altering workflows, and the potential impact of using the tool in their setting. Investigators will conduct summative qualitative focus group discussions in all participating clinics after 6 months of clinic participation. The study will provide important information on barriers and facilitators of embedding NPT-PLA interventions in \"real-world\" primary care clinical settings.",[28],[675,676,677,678,679,680,681],"colorectal carcinoma","implementation science","cancer prevention","cancer screening","normalization process theory","participatory health research","cluster randomized trial","2026-03-09",{"date":684,"type":49},"2026-03-10",{"date":686,"type":49},"2025-04-30",{"date":688,"type":20},"2029-04-30",{"name":690,"class":148},"University of Kansas Medical Center",""]