drugset / Trial / NCT05471843

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

NCT05471843

Phase 1/2 Active not recruiting 125 enrolled BeiGene
NaSingle-groupOpen-labelTreatment

Summary

The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.

Timeline

Start
2022-09-05
Primary completion
2025-07-18
Completion
2027-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Sonrotoclax Other / unclassified 160 mg Oral
Subject Sonrotoclax Other / unclassified 320 mg Oral

Indications