[{"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:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100462646","phase-1-a-phase-1a1b-study-of-elvn-001-for-the-treatment-chronic-myeloid-leukemia-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":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Chronic Myeloid Leukemia","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Cml",[15,31,32,33,34,35,36],"Tyrosine kinase inhibitor","T315I","T315I mutant","BCR-ABL","ENABLE","active site inhibitor of BCR-ABL","RECRUITING","2026-03-31",{"date":40,"type":41},"2026-04-01","ACTUAL",{"date":43,"type":41},"2022-05-22",{"date":45,"type":21},"2027-12",{"name":47,"class":48},"Enliven Therapeutics","INDUSTRY",45,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":15,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100576580","phase-1-elvn-001-for-the-treatment-of-chronic-myeloid-leukemia-with-and-without-t315i-mutation-in-japanese-participants-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":58,"type":21},21,[24],"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.",[62,63],"CML (Chronic Myelogenous Leukemia)","Chronic Phase CML",[15,65,32,66,34],"Tyrosine Kinase Inhibitor","T315I Mutant","2025-06-27",{"date":69,"type":41},"2025-07-01",{"date":71,"type":41},"2025-01-23",{"date":73,"type":21},"2028-01",{"name":47,"class":48},4,""]