Brief Summary
This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 (sonrotoclax) in participants with relapsed/refractory Waldenström’s Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.
Intervention / Treatment
- Drug: BGB-11417
- Drug: Zanubrutinib
Inclusion Criteria
- Clinical and definitive histologic diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of WM.
- Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström’s Macroglobulinemia (IWWM).
- For Cohorts 1-3, refractory or relapsed disease to the most recent therapy at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.
- For Cohort 4, patients must not have received prior therapy for WM.
- Adequate organ function.