Study to Evaluate the Efficacy and Safety of Sonrotoclax in Participants With Waldenström's Macroglobulinemia

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05952037

Patient View

This study assesses the safety and efficacy of sonrotoclax, alone or with zanubrutinib, in treating relapsed/refractory and untreated Waldenström's Macroglobulinemia. It involves 105 participants, requires a histologic diagnosis, and adequate organ function. Sonrotoclax and zanubrutinib are administered orally. The study spans approximately 5 years.

Patient Parameters

Program Overview

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.

Description

This study will test whether BGB-11417 (sonrotoclax) 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 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.

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. Treatments will continue until participants experience worsening disease status, too many side effects, or withdraw consent.

Eligibility Criteria

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 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.

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.

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