A Phase 2 study to evaluate the efficacy and safety of BGB-11417 in Patients with MCL
Research type
Research Study
Full title
A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Bcl-2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma
IRAS ID
1006621
Contact name
Kajal Patel
Contact email
Sponsor organisation
BeiGene Ltd
Clinicaltrials.gov Identifier
Research summary
This is an open-label study, which means that the participants, study doctor, and the research team know that the participant is receiving study drug and know which doses the participant receives. This study aims to determine the range of the study drug doses that can be safely used, the safest dosing schedule to minimise side effects when first taking the study drug, what side effects may be experienced when taking this drug, how the body processes this drug, and if this drug is effective against the participants Mantle Cell Lymphoma (MCL). The study consists of two parts. Part 1 determines the safety and tolerability of the study drug. Part 1 consists of 2 part, Part 1A and Part 1B. Part 1A will be the dose escalation portion, meaning that the first few participants who enter the study will be given the smallest dose of study drug. If this dose is well-tolerated, the next group of participants will receive a slightly higher dose. The study drug dose will be increased gradually until the highest planned dose is tested. Part 1B will be a safety expansion. The aim of Part 1B is to collect more information to choose the recommended dose of study drug to use in future studies. Part 2 evaluates efficacy of the study drug. This is a global research study including countries such as China, France, Spain, Germany, Poland, Italy, Israel, United States and the United Kingdom. The research study is conducted and funded by BeiGene, Ltd. Approximately 83 to 98 participants, with approximately 15 to 30 participants in Part 1, and approximately 68 patients in Part 2.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0268
Date of REC Opinion
8 Jun 2023
REC opinion
Further Information Favourable Opinion