A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Eff
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). The study has two parts: Part 1 of the trial (Dose E
| Condition(s) | Chronic Myeloid Leukemia, Chronic Phase, Chronic Myeloid Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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). 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 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. In bo |
| Who can participate | 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 * Have received treatment with at least one prior TKI and have treatment failure, suboptimal response, or treatment intolerance * Prior treatment with asciminib is allowed * Adequate organ function, as assessed by local laboratory Key Exclusion Criteria: * 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Terns, Inc. |
| Locations | Birmingham, Alabama, United States; Gilbert, Arizona, United States; Orange, California, United States; Lone Tree, Colorado, United States; Fort Myers, Florida, United States; Ocala, Florida, United States (+48 more sites) |
| Start date | 2024-03-26 |
| NCT ID | NCT06163430 |
| Official listing | https://clinicaltrials.gov/study/NCT06163430 |