Status:
RECRUITING
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Lead Sponsor:
Enliven Therapeutics
Conditions:
Chronic Myeloid Leukemia
Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 with...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05304377
Start Date
May 22 2022
End Date
December 1 2026
Last Update
January 9 2026
Active Locations (46)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
Montefiore Medical Center
The Bronx, New York, United States, 10461
3
Oregon Health & Science University-Knight Cardiovascular Institute
Portland, Oregon, United States, 97239
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030