[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576580":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":72,"collaborators":24,"id":74,"slug":24,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":24,"enrollmentInfo":83,"targetDuration":24,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Enliven Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 Dose Escalation","EXPERIMENTAL","ELVN-001 administered in 3+3 dose escalation",[13],"Drug: ELVN-001",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2 Dose Exploration","ELVN-001 administered to approximately 6 participants per dose level who may be enrolled at or below the dose levels that have been deemed safe and tolerable in Part 1",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","ELVN-001","Orally once or twice daily",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Helen Collins, MD","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Yuzo Tomonaga","CONTACT","+81-3-6779-8000","ClinicalTrialInformation@cmic.co.jp",[36,49,60,66],{"facility":37,"status":38,"city":39,"state":39,"zip":24,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Akita University Hospital","RECRUITING","Akita","Japan",{"type":42,"coordinates":43},"Point",[44,45],140.11667,39.71667,{"lat":45,"lon":44},[48],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":24},{"facility":50,"status":38,"city":51,"state":52,"zip":24,"country":40,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Aiiku Hospital","Sapporo","Hokkaido",{"type":42,"coordinates":54},[55,56],141.35,43.06667,{"lat":56,"lon":55},[59],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":24},{"facility":61,"status":38,"city":62,"state":63,"zip":24,"country":40,"cosmosGeoPoint":24,"geoPoint":24,"contacts":64},"The University of Osaka Hospital","Suita-shi","Osaka",[65],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":24},{"facility":67,"status":38,"city":68,"state":69,"zip":24,"country":40,"cosmosGeoPoint":24,"geoPoint":24,"contacts":70},"Tokyo Medical University Hospital","Shinjuku-ku","Tokyo",[71],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":24},{"type":73,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100576580",false,"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","CML","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.","ALL","18 Years",{"count":84,"type":85},21,"ESTIMATED","INTERVENTIONAL",[88],"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 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.",[91,92],"CML (Chronic Myelogenous Leukemia)","Chronic Phase CML",[79,94,95,96,97],"Tyrosine Kinase Inhibitor","T315I","T315I Mutant","BCR-ABL","2025-06-27",{"date":100,"type":101},"2025-07-01","ACTUAL",{"date":103,"type":101},"2025-01-23",{"date":105,"type":85},"2028-01",{"name":5,"class":6},4]