A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
NCT05952037 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114
Last updated 2026-01-02
Summary
This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.
Conditions
- Waldenstrom Macroglobulinemia
- Waldenstrom's Macroglobulinemia Recurrent
- Waldenstrom's Macroglobulinemia Refractory
Interventions
- DRUG
-
Sonrotoclax
Administered orally as a tablet.
- DRUG
-
Administered orally as a capsule.
Sponsors & Collaborators
-
BeOne Medicines
lead INDUSTRY
Principal Investigators
-
Study Director · BeOne Medicines
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-23
- Primary Completion
- 2026-09-22
- Completion
- 2028-08-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- China
- France
- Greece
- Italy
- Spain
- United Kingdom
Study Locations
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