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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":566,"type":567},180,"ESTIMATED","INTERVENTIONAL",[570,571],"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).",[574,575],"Chronic Myeloid Leukemia, Chronic Phase","Chronic Myeloid Leukemia",[577,578,41,579,580,581,561,582],"allosteric inhibitor of BCR-ABL1","CML","chronic myeloid leukemia","T315I","T315I mutant","HS-10382","2026-01-08",{"date":585,"type":586},"2026-01-12","ACTUAL",{"date":588,"type":586},"2024-03-26",{"date":590,"type":567},"2030-05-31",{"name":5,"class":6},54]