Myeloproliferative Neoplasms Clinical Trial
CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
Summary
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 Criteria
Key Inclusion Criteria:
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 Exclusion Criteria:
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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There is 1 Location for this study
Houston Texas, 77030, United States
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