A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Running, not enrolling · Phase 2

Conditions studied: Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory

In brief

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.

Key facts

Study ID

NCT05952037

Run by

BeOne Medicines

People needed

114

Starts

2023-10-23

Expected to finish

2028-08-01

Last updated by the study team

2026-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical and definitive histologic diagnosis 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 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 (except for plasmapheresis).
• Adequate organ function.

You may not qualify if…

• Central nervous system (CNS) involvement by WM.
• Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
• History of other malignancies ≤ 2 years before study entry.
• Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug.
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Northwestern Medicine Cancer Center — Warrenville, Illinois, United States
• Mission Cancer and Blood — Waukee, Iowa, United States
• University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Hattiesburg Hematology and Oncology Clinic — Hattiesburg, Mississippi, United States
• Memorial Sloan Kettering Cancer Center Mskcc — New York, New York, United States
• Atrium Health Levine Cancer Institute (Lci) — Charlotte, North Carolina, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Ut Southwestern Medical Center — Dallas, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Virginia Commonwealth University Massey Cancer Center — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• Genesiscare North Shore — St Leonards, New South Wales, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Flinders Medical Centre — Bedford PK, South Australia, Australia
• Monash Health — Clayton, Victoria, Australia
• St Vincents Hospital Melbourne — Fitzroy, Victoria, Australia
• Linear Clinical Research — Nedlands, Western Australia, Australia
• Royal Perth Hospital — Perth, Western Australia, Australia
• City of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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