An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05304377.
