Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05304377

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

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

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
250 (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 patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to 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 do not tolerate or benefit from available TKIs.

Conditions

Interventions

TypeNameDescription
DRUGELVN-001orally once or twice daily

Timeline

Start date
2022-05-22
Primary completion
2027-12-01
Completion
2027-12-01
First posted
2022-03-31
Last updated
2026-04-01

Locations

45 sites across 14 countries: United States, Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, South Korea, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT05304377. Inclusion in this directory is not an endorsement.