A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEnliven Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ELVN-001
Treatment groups
250 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov