[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Terns, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100528642","phase-1-a-phase-12-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-efficacy-of-tern-701-in-participants-with-chronic-myeloid-leukemia-cardinal-100528642",false,"NCT06163430","A Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)","A Phase 1\u002F2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia","CARDINAL","Key Inclusion Criteria:\n\n* Male or female participants ≥ 18 years of age at the time of signing the informed consent\n* Have an ECOG performance status score of 0 to 2\n* Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase\n* Have received treatment with at least one prior TKI and have treatment failure, suboptimal response, or treatment intolerance\n* Prior treatment with asciminib is allowed\n* Adequate organ function, as assessed by local laboratory\n\nKey Exclusion Criteria:\n\n* Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of TERN-701\n* Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)","ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML).\n\nThe study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily.\n\nPart 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of 2 recommended dose levels for expansion selected from Part 1. Part 2m (mutation cohort) will further evaluate the efficacy and safety of 500mg of TERN-701 in previously treated CP-CML participants with certain resistance mutations.\n\nIn both Part 1 and Part 2, participants will receive continuous once daily dosing of TERN-701 divided into 28-day cycles. During the treatment period, participants will have scheduled visits to the trial center at Cycle 1 day 1(C1D1), C1D2 (Part 1 only), C1D8, C1D15, and C1D16 (Part 1 only), followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter.\n\nApproximately 180 participants could be enrolled in this trial, up to 80 participants in Part 1 (dose escalation), including optional backfill cohorts, approximately 80 participants in Part 2 (randomized dose expansion), and approximately 20 participants in Part 2m (mutation cohort).\n\nAll participants will receive active trial intervention.\n\nFour dose-level cohorts have been evaluated in Part 1; two dose levels will be evaluated in Part 2 (Randomized Dose Expansion), and one dose level will be evaluated in Part 2m (mutation cohort).",[28,29],"Chronic Myeloid Leukemia, Chronic Phase","Chronic Myeloid Leukemia",[31,32,33,34,35,36,15,37],"allosteric inhibitor of BCR-ABL1","CML","TERN-701","chronic myeloid leukemia","T315I","T315I mutant","HS-10382","RECRUITING","2026-01-08",{"date":41,"type":42},"2026-01-12","ACTUAL",{"date":44,"type":42},"2024-03-26",{"date":46,"type":21},"2030-05-31",{"name":48,"class":49},"Terns, Inc.","INDUSTRY",54,""]