BGB-11417- 302 A Phase 3 Randomized DoubleBlind Multicenter Study of Sonrotoclax Plus Zanubrutinib
Research type
Research Study
Full title
A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
IRAS ID
1010995
Contact name
Mandeep Kalia
Contact email
Sponsor organisation
BeiGene Ltd
Eudract number
2024-515593-27
Research summary
The purpose of this study is to test if sonrotoclax in combination with zanubrutinib is safe and works better in treating adult patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) comparing it with when zanubrutinib is given in combination with sonrotoclax-matched placebo (the placebo is an inactive dummy drug that looks like the sonrotoclax medication).
Zanubrutinib works by blocking a protein called Bruton tyrosine kinase (BTK). BTK helps cancer cells to grow. By blocking BTK, zanubrutinib interferes with the signals needed for the cancer cells to multiply and survive. This helps slow down or stop the growth of cancer cells and can reduce the number of cancer cells.
Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (BCL2). This protein helps cancer cells avoid programmed death that happens in normal cells and therefore helps cancer cells to stay alive. Blocking BCL2 could help kill MCL cells and make MCL shrink.
300 participants will be randomised (having an equal chance like flipping a coin) to receive either sonrotoclax in combination with zanubrutinib (Arm A) or sonrotoclax-matched placebo in combination with zanubrutinib (Arm B). This is a double-blind study which means that neither the participant nor the study doctors will know which treatment Arm a participant has been assigned to.
Starting Cycle 1 Day 1, all participants will start zanubrutinib (taken orally) at a dose of 320 mg once daily or 160 mg twice daily until progressive disease, unacceptable side-effects or they are told to stop. On Cycle 2 Day 1, sonrotoclax (Arm A participants) / sonrotoclax-matched placebo (Arm B participants) will start (taken orally) once daily using the twice-a-week ramp-up schedule (where the dose is increased) until the target dose of 320 mg is reached until Cycle 25 Day 28. A cycle is 28 days. Participation in the study is likely to last about 60 months and involve 32-38 visits.REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0017
Date of REC Opinion
11 Feb 2025
REC opinion
Further Information Favourable Opinion