PhI Efficacy of Single&Multiple Doses of Oral AdminHS-10382 (TERN-701) in Ps w/Chronic Myeloid Leuk
Study Description
The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a novel highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML).
The study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily.
Part 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of at least 2 recommended dose levels for expansion selected from Part 1.
In both Part 1 and Part 2, participants will receive continuous 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, C1D8, C1D15, and C1D16, followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter.
Approximately 60 to 80 participants could be enrolled in this trial, including approximately 24 to 36 participants in Part 1 (dose escalation), including optional backfill cohorts, and approximately 40 participants in Part 2 (randomized dose expansion).
All participants will receive active trial intervention.
Up to 4 dose-level cohorts may be evaluated in Part 1; at least 2 dose levels may be evaluated in Part 2.
Eligibility
-Male or female participants >= 18 years of age at the time of signing the informed consent
-Have an ECOG performance status score of 0 to 2
-Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase with or without T315l mutation
-Have received treatment with active site targeting TKIs and have treatment failure, suboptimal response, or treatment intolerance
-Participants who are intolerant of asciminib, and do not have resistant/relapsing disease
-Adequate organ function, as assessed by local laboratory
Key
--CML in accelerated or blast phase
Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of TERN-701
-Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to <= Grade 2 or baseline)
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