[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Enliven Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100462646",false,"NCT05304377","A Phase 1a\u002F1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia","A Phase 1a\u002F1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia","CML","Inclusion Criteria:\n\n* BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.\n* US: The patient has failed or is intolerant to at least one prior second-generation tyrosine kinase inhibitor (TKI) or asciminib. Rest of World: The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML (country-specific criteria may vary).\n* ECOG performance status of 0 to 2.\n* Adequate hematologic, hepatic and renal function.\n* Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.\n\nExclusion Criteria:\n\n* Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.\n* History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.\n* QTc \\>470 ms.","ALL","18 Years",{"count":19,"type":20},250,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.",[26,27,28],"Chronic Myeloid Leukemia","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Cml",[14,30,31,32,33,34,35],"Tyrosine kinase inhibitor","T315I","T315I mutant","BCR-ABL","ENABLE","active site inhibitor of BCR-ABL","RECRUITING","2026-03-31",{"date":39,"type":40},"2026-04-01","ACTUAL",{"date":42,"type":40},"2022-05-22",{"date":44,"type":20},"2027-12",{"name":46,"class":47},"Enliven Therapeutics","INDUSTRY",45,{"id":50,"slug":4,"hasResults":10,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":14,"eligibilityCriteria":54,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100576580","NCT06787144","ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants","A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants","Inclusion Criteria:\n\n* BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.\n* ECOG performance status of 0 to 2.\n* The patient was born in Japan and both parents and grandparents are Japanese.\n* Adequate hematologic, hepatic and renal function.\n* Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.\n\nExclusion Criteria:\n\n* Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.\n* History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.\n* QTc \\>470 ms.",{"count":56,"type":20},21,[23],"The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.",[60,61],"CML (Chronic Myelogenous Leukemia)","Chronic Phase CML",[14,63,31,64,33],"Tyrosine Kinase Inhibitor","T315I Mutant","2025-06-27",{"date":67,"type":40},"2025-07-01",{"date":69,"type":40},"2025-01-23",{"date":71,"type":20},"2028-01",{"name":46,"class":47},4,""]