OncRef

Clinical Trial: NCT05471843

Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:BeOne Medicines
Information Provided By:BeOne Medicines
Last Update Posted:2026-09-22

Study Overview

Brief Summary

The study consists of two parts. Part 1 determines the safety and tolerability of sonrotoclax monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of sonrotoclax monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of sonrotoclax monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.

Official Title

A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Conditions

Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma

Intervention / Treatment

  • Drug: Sonrotoclax

Other Study ID Numbers

  • BGB-11417-201
  • 2022-500687-35-00
  • CTR20221815

Start Date (Actual)

2022-09-05

Primary Completion Date (Actual)

2025-07-18

Study Completion Date (Estimated)

2027-01-31

Enrollment (Actual)

125

Study Type

Interventional

Phase

Phase 1, Phase 2