A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
• Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.
Locations
Other Locations
Japan
Akita University Hospital
RECRUITING
Akita
Aiiku Hospital
RECRUITING
Sapporo
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
The University of Osaka Hospital
RECRUITING
Suita-shi
Contact Information
Primary
Yuzo Tomonaga
ClinicalTrialInformation@cmic.co.jp
+81-3-6779-8000
Time Frame
Start Date: 2025-01-23
Estimated Completion Date: 2028-01
Participants
Target number of participants: 21
Treatments
Experimental: Part 1 Dose Escalation
ELVN-001 administered in 3+3 dose escalation
Experimental: Part 2 Dose Exploration
ELVN-001 administered to approximately 6 participants per dose level who may be enrolled at or below the dose levels that have been deemed safe and tolerable in Part 1
Related Therapeutic Areas
Sponsors
Leads: Enliven Therapeutics