[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microsatellite-stable-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microsatellite-stable-colorectal-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,63,108],{"id":9,"slug":10,"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":25,"conditions":26,"keywords":38,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100431255","phase-1-a-study-of-bms-986340-as-monotherapy-and-as-combination-therapy-in-participants-with-advanced-solid-tumors-100431255",false,"NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},1109,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[27,28,29,30,31,32,33,34,35,36,37],"Cervical Cancer","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Non-Small-Cell Lung Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Urothelial Carcinoma","Pancreatic Adenocarcinoma","Melanoma","Ovarian Neoplasms","Triple Negative Breast Neoplasms",[39,27,40,41,42,28,43,29,44,45,30,46,47,31,32,33,34,35,36,37,48,49],"BMS-986340","CRC","First-in-human","GEJ","HNSCC","MSS CRC","Nivolumab","NSCLC","SCCHN","Docetaxel","Pumitamig","RECRUITING","2026-06-29",{"date":53,"type":54},"2026-06-30","ACTUAL",{"date":56,"type":54},"2021-05-27",{"date":58,"type":20},"2031-08-31",{"name":60,"class":61},"Bristol-Myers Squibb","INDUSTRY",47,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":89,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100509886","phase-1-fog-001-in-locally-advanced-or-metastatic-solid-tumors-100509886","NCT05919264","FOG-001 in Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and marrow function.\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1g):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic solid tumor that is non-MSI-H or non-dMMR colorectal cancer (CRC) or any other solid tumor with documented WNT- pathway activating mutations (WPAMs).\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic non-MSI-H or non-dMMR CRC.\n* At least one lesion that is suitable for a core needle biopsy.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):\n\n* Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d):\n\n* Desmoid tumor (aggressive fibromatosis)\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n* One dose of mFOLFOX6 with or without bevacizumab in the unresectable or metastatic setting prior to enrollment is allowed.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab\n\n* Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.\n* MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1\u002FPD-L1\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine\u002FTipiracil + Bevacizumab\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2a):\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2b):\n\n* Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence\n\nExclusion Criteria:\n\n* Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC.\n* Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.\n* Osteoporosis, which is defined as a T-score of ≤-2.5 at the lumbar spine (L1 - L4), left (or right) femoral neck or left (or right) total hip as determined by DXA scan.\n* Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)\n* Unstable\u002Finadequate cardiac function.\n* Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.\n* Pregnant, lactating, or planning to become pregnant.",{"count":71,"type":20},595,[23,24],"The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors.",[75,76,77,78,79,80,81,82,29,83,84,85,86,87,88],"Cancer","Colorectal Cancer","Solid Tumor","Locally Advanced Solid Tumor","Metastatic Cancer","WNT Pathway","HCC","Desmoid","Metastatic Castration-resistant Prostate Cancer","FAP","Endometrial Carcinoma","Prostate Cancer","Microsatellite Instability-High Colorectal Cancer","Adamantinomatous Craniopharyngioma",[75,77,78,79,90,91,92,82,93,94,95,96,97],"WNT Pathway Activating Mutation (WPAM)","Colorectal Cancer (CRC)","Microsatellite Stable (MSS)","Hepatocellular Carcinoma (HCC)","Adenomatous Polyposis Coli (APC)","β-catenin","Beta-catenin","CTNNB1","2026-05-26",{"date":100,"type":54},"2026-05-28",{"date":102,"type":54},"2023-05-23",{"date":104,"type":20},"2027-08-31",{"name":106,"class":61},"Parabilis Medicines, Inc.",33,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100550264","phase-1-a-study-of-vet3-tgi-in-patients-with-solid-tumors-100550264","NCT06444815","A Study of VET3-TGI in Patients With Solid Tumors","A Phase 1\u002F1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors","STEALTH-001","Key Inclusion Criteria:\n\n* Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.\n* Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab\u002FPDL1 antibodies), and chemotherapy\n* Measurable disease as per RECIST 1.1 criteria\n* At least one tumor amenable to safe ITu injections and\u002For biopsies\n* ECOG performance status 0 or 1\n* Demonstrate adequate organ function\n* Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions\n\nAdditional Inclusion criteria exist\n\nKey Exclusion Criteria:\n\n* Prior systemic therapy washout (dependent upon the therapy)\n* Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.\n* CNS metastases and\u002For carcinomatous meningitis that have not been completely resected or completely irradiated.\n* Prior history of myocarditis\n* Known HIV\u002FAIDS, active HBV or HCV infection.\n* Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).\n\nAdditional Exclusion criteria exist",{"count":117,"type":20},60,[23],"VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).",[121,29,122,27,123,124,125,126,127,128,129,130,131],"Solid Tumor, Adult","Head and Neck Squamous Cell Carcinoma","Kidney Cancer","Renal Cell Carcinoma","Melanoma Stage IV","Merkel Cell Carcinoma of Skin","Mesothelioma","Non-small Cell Lung Cancer","Cutaneous Squamous Cell Carcinoma (CSCC)","Urothelial Carcinoma Bladder","Squamous Cell Carcinoma","2026-04-01",{"date":134,"type":54},"2026-04-07",{"date":136,"type":54},"2024-09-16",{"date":138,"type":20},"2027-12-31",{"name":140,"class":61},"KaliVir Immunotherapeutics",7]