[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576580":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":73,"collaborators":24,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":24,"enrollmentInfo":85,"targetDuration":24,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"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",[36,50,61,67],{"facility":37,"status":38,"city":39,"state":39,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Akita University Hospital","RECRUITING","Akita","Japan","JP",{"type":43,"coordinates":44},"Point",[45,46],140.11667,39.71667,{"lat":46,"lon":45},[49],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":24},{"facility":51,"status":38,"city":52,"state":53,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Aiiku Hospital","Sapporo","Hokkaido",{"type":43,"coordinates":55},[56,57],141.35,43.06667,{"lat":57,"lon":56},[60],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":24},{"facility":62,"status":38,"city":63,"state":64,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":24,"geoPoint":24,"contacts":65},"The University of Osaka Hospital","Suita-shi","Osaka",[66],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":24},{"facility":68,"status":38,"city":69,"state":70,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":24,"geoPoint":24,"contacts":71},"Tokyo Medical University Hospital","Shinjuku-ku","Tokyo",[72],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":24},{"type":74,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100576580","phase-1-elvn-001-for-the-treatment-of-chronic-myeloid-leukemia-with-and-without-t315i-mutation-in-japanese-participants-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":86,"type":87},21,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93,94],"CML (Chronic Myelogenous Leukemia)","Chronic Phase CML",[81,96,97,98,99],"Tyrosine Kinase Inhibitor","T315I","T315I Mutant","BCR-ABL","2025-06-27",{"date":102,"type":103},"2025-07-01","ACTUAL",{"date":105,"type":103},"2025-01-23",{"date":107,"type":87},"2028-01",{"name":5,"class":6},4]