ELVN-001_Phase1a/1b Study in Myeloid Leukaemia
Research type
Research Study
Full title
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
IRAS ID
1010547
Contact name
Damiette Smit
Contact email
Sponsor organisation
Enliven Therapeutics Inc.
Eudract number
2022-000052-11
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test the safety and early signs of efficacy for a research medicine called ELVN-001. It is a phase 1 study, which means the research medicine has not yet been tested in people. ELVN-001 is a capsule designed for the treatment of chronic myelogenous leukaemia (also abbreviated to CML). The study aims to test different doses of ELVN-001 to see which dose is safer in people and whether it is an effective treatment for CML.
Participants who meet all the criteria to take part in the study, will enter the Treatment Period and receive ELVN-001 daily for 28 days (also called a Cycle). ELVN-001 will be provided as either 10mg or 40mg capsules. Participants will be asked to take one or more capsule(s) orally (by mouth) once or twice daily for each 28-day cycle, depending on which study treatment participants are assigned to. Participants will continue receiving ELVN-001 until either they experience unacceptable side effects, the disease progresses, they or their study investigator decide to stop treatment, they are not responding to the study medicine, they become pregnant, or the study is stopped by the Sponsor or other regulatory authorities.
Approximately 180 participants are expected to participate in this study across approximately 40 different treatment sites around the world.
REC name
West of Scotland REC 1
REC reference
24/WS/0138
Date of REC Opinion
6 Nov 2024
REC opinion
Further Information Favourable Opinion