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 groupsLocations
45Australia
Royal Adelaide HospitalSA 5000, Adelaide Australia
Belgium
UZ Gent9000, Ghent Belgium
UZ Leuven3000, Leuven Belgium
CHU Liege4000, Liège Belgium
Sponsors and collaborators
Enliven Therapeutics
Lead sponsor
Source ClinicalTrials.gov