NCT06787144

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

A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Enliven Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.

Detailed description

This first-in-human trial with ELVN-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (RDEs) of single agent ELVN-001 in chronic phase CML with or without T315I mutations. The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed together with an evaluation of changes in BCR-ABL1 transcript. An understanding of the safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development of ELVN-001 in adults with CML. By virtue of its predicted pharmacological profile ELVN-001 has the potential to be tolerable and achieve a deep molecular response in patients with CML with or without T315I mutations who have failed, or are intolerant to, or not a candidate for, at least 2 prior TKIs.

Conditions

• CML (Chronic Myelogenous Leukemia)
• Chronic Phase CML

Interventions

Type	Name	Description
DRUG	ELVN-001	Orally once or twice daily

Timeline

• Start date: 2025-01-23
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-01-22
• Last updated: 2025-07-01

Locations

4 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study