Tests ELVN-001 in adults with chronic myeloid leukemia
Tests the new drug ELVN-001 for safety in adults with chronic myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Key facts
- Where
- Adelaide, AustraliaSee the site
- Phase
- Phase 1
Where in Australia
- Royal Adelaide HospitalAdelaide, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Enliven Therapeutics
- Trial code
- NCT05304377EU 2023-503335-18-00
- Record updated
- 1 April 2026
- Original description
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.Read full original descriptionShow less
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
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.
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.