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Evaluating ELVN-001 for treating Chronic Myeloid Leukemia

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

Phase 1 Interventional Enliven Therapeutics · NCT05304377

This study is testing a new treatment called ELVN-001 for people with chronic myeloid leukemia who haven't responded well to current therapies, to see if it can help them better.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorEnliven Therapeutics Industry-sponsored
Drugs / interventionsasciminib
Locations45 sites (New York, New York and 44 other locations)
Trial IDNCT05304377 on ClinicalTrials.gov

What this trial studies

This clinical trial is a first-in-human, dose escalation study aimed at assessing the safety, tolerability, and pharmacokinetics of ELVN-001 in patients with chronic myeloid leukemia (CML), particularly those with T315I mutations. The study will evaluate the recommended dose for further clinical evaluation and monitor changes in BCR-ABL1 transcripts. Patients who have relapsed, are refractory, or intolerant to existing tyrosine kinase inhibitors (TKIs) will be included. The trial seeks to provide preliminary evidence of anti-CML activity and inform future development of ELVN-001.

Who should consider this trial

Good fit: Ideal candidates are adults with BCR-ABL1 positive CML in chronic phase, particularly those who have failed or are intolerant to existing treatments.

Not a fit: Patients currently receiving anti-cancer therapies or those with active chronic pancreatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with CML who have not responded to current therapies.

How similar studies have performed: Other studies have shown promise with similar approaches targeting T315I mutations in CML, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.
* US: The patient has failed or is intolerant to at least one prior second-generation tyrosine kinase inhibitor (TKI) or asciminib. Rest of World: The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML (country-specific criteria may vary).
* 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.

Where this trial is running

New York, New York and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Myeloid LeukemiaChronic Phase Chronic Myeloid Leukemia, BCR-ABL1 PositiveCmlCMLTyrosine kinase inhibitorT315IT315I mutantBCR-ABL
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.