Phase 1a1b Study of ELVN-001, an Oral Drug for Treating Chronic Myeloid Leukemia With or Without T315I Mutation

What this Trial Is About

Researchers are evaluating ELVN-001, an investigational drug, in adults with chronic myeloid leukemia CML, including those with a specific T315I mutation. This early-phase trial aims to find safe and tolerable doses for further study, especially in patients who have relapsed, are resistant, or cannot tolerate current tyrosine kinase inhibitors TKIs. The study also examines how ELVN-001 affects disease markers and its overall safety profile. The trial includes a dose escalation phase to identify recommended doses, followed by dose expansion phases that treat patients with or without the T315I mutation at those doses. ELVN-001 is given orally once or twice daily. Participants receive the drug as a single agent, and the study monitors responses and safety during these phases. Participants will undergo regular assessments including monitoring for side effects, laboratory tests, heart evaluations, and measurement of molecular responses related to CML over periods ranging from 28 days up to 3 years. The study tracks drug levels in the body for up to 6 months and evaluates long-term outcomes such as complete blood responses. Overall participation duration varies, with close safety follow-up throughout.

A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia