ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
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 Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
Eligibility criteria
Qualifiers
BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
ECOG performance status of 0 to 2.
The patient was born in Japan and both parents and grandparents are Japanese.
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
21 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov