A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Recruiting now · Phase 1
Conditions studied: Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, 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 patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.
Key facts
- Study ID
- NCT05304377
- Run by
- Enliven Therapeutics
- People needed
- 250
- Starts
- 2022-05-22
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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
- The Christie NHS Foundation Trust — Manchester, United Kingdom (enrolling)
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- Oregon Health & Science University-Knight Cardiovascular Institute — Portland, Oregon, United States (enrolling)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Royal Adelaide Hospital — Adelaide, Australia (enrolling)
- UZ Gent — Ghent, Belgium (enrolling)
- UZ Leuven — Leuven, Belgium (enrolling)
- CHU Liege — Liège, Belgium (enrolling)
- University Health Network (UHN) - Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
- CHU Amiens Picardie Site Sud — Amiens, France (enrolling)
- Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux, France (enrolling)
- CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille — Lille, France (enrolling)
- Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren — Limoges, France (enrolling)
- Centre Leon Berard — Lyon, France (enrolling)
- Uijeongbu Eulji Medical Center — Gyeonggi-do, South Korea (enrolling)
- Hospital Del Mar — Barcelona, Spain (enrolling)
- Hospital Universitario La Paz — Madrid, Spain (enrolling)
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) — Valencia, Spain (enrolling)
- Beatson West of Scotland Cancer Centre, Gartnavel General Hospital — Glasgow, United Kingdom (enrolling)
- Hammersmith Hospital Imperial College Healthcare NHS Trust — London, United Kingdom (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Uniklinik RWTH Aachen Medizinische — Aachen, Germany (enrolling)
- Charite Campus Virchow — Berlin, Germany (enrolling)
- Klinikum der Goethe Universitat — Frankfurt, Germany (enrolling)
- Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes — Homburg, Germany (enrolling)
Full record on ClinicalTrials.gov
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