ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants

Launched by ENLIVEN THERAPEUTICS · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial, called a Phase 1 Study of ELVN-001, is looking at a new treatment for chronic myeloid leukemia (CML), a type of blood cancer, in Japanese patients. The main goal is to see how safe the treatment is, how well it is tolerated, and to find the right dose to use in future studies. This trial is specifically for patients who have already tried at least two other treatments for CML, known as TKIs, but either did not have success with them, could not tolerate them, or are not suitable candidates for these therapies.

To participate, patients need to have a specific genetic marker (BCR::ABL1 positive) and must have been born in Japan, with Japanese ancestry. They should also have good overall health, meaning their blood and organ functions are stable. Participants in the trial can expect close monitoring by medical professionals as they receive the new treatment, and they will help researchers understand how effective and safe ELVN-001 is. This study is currently looking for participants aged 65 to 74, and it welcomes all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
• • ECOG performance status of 0 to 2.
• • The patient was born in Japan and both parents and grandparents are Japanese.
• • Adequate hematologic, hepatic and renal function.
• • Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.
• Exclusion Criteria:
• • Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
• • History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.
• • QTc \>470 ms.