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

Status: closed to accrual

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.

Inclusion Criteria

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.

Exclusion Criteria

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.

This study will test whether sonrotoclax (BGB-11417) can be used to improve outcomes in

participants with Waldenström's Macroglobulinemia (WM) both when used alone in those who

have not responded well to conventional treatments and when used in combination with

zanubrutinib in those who have not yet received treatment. The main goals of the study

are to determine how many participants 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.

BCL2 is a key protein involved in cell death, and abnormal levels of BCL2 are associated

with many cancers. Blocking the action of BCL2 proteins is a promising approach with

potential therapeutic benefits in participants with different types of cancers, including

WM. This study will enroll approximately 105 participants. All participants will receive

sonrotoclax orally as a tablet.

The study will take place at multiple centers worldwide. The overall time to participate

in this study is approximately 5 years.

Note: Our company, previously known as BeiGene, is now officially BeOne Medicines.

Because some of our older studies were sponsored under the name BeiGene, you may see both

names used for this study on this website.

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

Inclusion Criteria

Exclusion Criteria

United States

Maryland

Baltimore

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

Description

Eligibility Criteria

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Trial Objectives and Outline

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