Summary
Study overview
The study will test whether BCL2 inhibitor called sonrotoclax (also known as BGB-11417) can be used to improve outcomes in people with Waldenström's Macroglobulinemia (WM) both when used alone in those who have not responded well to conventional treatments (relapsed/refractory), and when used in combination with zanubrutinib targeted therapy in those who have not yet recreived treatment (previously untreated).
The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment, and to determine what adverse events, or side effects, participants might experience.
The study will take place at multiple centres worldwide. The overall time to participats in this study is approximately 5 years.
Study cohorts
Eligible participants will be allocated to a treatment cohort based on their previous treatment history.
Participants with relapsed/refractory (R/R) WM will be enrolled in either Cohort 1, 2 or 3 based on whether they were R/R to:
- BTK inhibitor and anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor (Cohort 1)
- Anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor and were intolerant to BTK inhibitor (Cohort 2)
- BTK inhibitor treatment and are unsuitable for chemoimmunotherapy (Cohort 3)
Cohorts 1, 2 and 3 will all receive sonrotoclax at a standard dose, given orally once daily.
Participants with previously untreated WM will be enrolled in Cohort 4, and will receive sonrotoclax and zanubrutinib combination therapy, both given as oral tablets.