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A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Trial Status: active
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 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05304377.
