Evaluating ELVN-001 for treating Chronic Myeloid Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Recruiting
• Oregon Health & Science University-Knight Cardiovascular Institute
  Portland, Oregon, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Royal Adelaide Hospital
  Adelaide, Australia Recruiting
• UZ Gent
  Ghent, Belgium Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: ELVN-001-101@enliventherapeutics.com
• Phone: 707-799-3272

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.