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

Launched by ENLIVEN THERAPEUTICS · Mar 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ELVN-001 for people with Chronic Myeloid Leukemia (CML), a type of blood cancer. The goal is to learn about the safety of ELVN-001 and find out the best dose to use in future studies. This trial is open to adults aged 65 to 74 who have been diagnosed with CML and either have a specific genetic mutation (called T315I) or do not have it. To qualify, patients must have had difficulties with other treatments or not be suitable for them, and they should have stable health for their blood, liver, and kidneys.

Participants in this study will receive ELVN-001 and will be monitored closely by the medical team for any side effects or reactions. It's important to know that certain patients, such as those who have recently received other cancer treatments or have specific health issues, may not be eligible. This trial is currently recruiting participants, and it aims to provide hope for those who have not had success with other therapies for their CML.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.
• • The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML.
• • ECOG performance status of 0 to 2.
• • 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.