BGB-11417-103 Phase 1b/2, Dose Finding, Expansion Study of BGB-11417 in Myeloid malignancies
Research type
Research Study
Full title
A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
IRAS ID
1007256
Contact name
Kajal Patel
Contact email
Sponsor organisation
BeiGene, Ltd
Eudract number
2021-003285-12
Clinicaltrials.gov Identifier
Research summary
This study will look at the safety and tolerability of an investigational anticancer medication, currently known as BGB-11417, when given in combination with azacitidine. BGB-11417 blocks a protein called B-cell lymphoma-2 (Bcl-2). Bcl-2 helps certain leukemia cells live and grow. By blocking Bcl-2, BGB-11417 can slow or stop leukemia cell growth and allow apoptosis to occur (the body's natural process to destroy unneeded cells), thereby causing leukemia cell death. This might lead to an improvement in the symptoms associated with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN). Azacitidine is a medication approved in some countries for the treatment of MDS, and AML. Azacitidine works by blocking the function of a protein called DNA methyltransferase, which is important for the leukemia cells to survive. Azacitidine has been used to treat some AML and MDS patients due to its low toxicity and ability to improve survival.
This study aims to determine the range of BGB-11417 doses and dosing schedules that can be used safely together with azacitidine to minimise side effects, that may be experienced by this combination treatment, how the body processes the medications, and if this combination treatment is effective against the participants cancer. This is an open-label study, which means that the participant, participants study doctor, and the research team know that the participant is receiving BGB-11417 and azacitidine and know which dose and dosing schedule the participant is receiving.REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0245
Date of REC Opinion
1 Dec 2023
REC opinion
Further Information Favourable Opinion