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

NCT05304377 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Chronic Myeloid Leukemia
  • Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
  • Cml

Interventions

DRUG

ELVN-001

orally once or twice daily

Sponsors & Collaborators

  • Enliven Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-22
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05304377 on ClinicalTrials.gov