ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
Recruiting now · Phase 1
Conditions studied: CML (Chronic Myelogenous Leukemia), Chronic Phase CML
In brief
The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
Key facts
- Study ID
- NCT06787144
- Run by
- Enliven Therapeutics
- People needed
- 21
- Starts
- 2025-01-23
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2025-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
- ECOG performance status of 0 to 2.
- The patient was born in Japan and both parents and grandparents are Japanese.
- Adequate hematologic, hepatic and renal function.
- Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.
You may not qualify if…
- 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 is running
- Akita University Hospital — Akita, Akita, Japan (enrolling)
- Aiiku Hospital — Sapporo, Hokkaido, Japan (enrolling)
- The University of Osaka Hospital — Suita-shi, Osaka, Japan (enrolling)
- Tokyo Medical University Hospital — Shinjuku-ku, Tokyo, Japan (enrolling)
Full record on ClinicalTrials.gov
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