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.
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Part 1 A + 1B: Dose escalation and safety expansion |
R/R MCL |
Sonrotoclax |
None |
Primary Endpoints: DLTs (part 1A), TEAEs, SAEs, AEs leading to discontinuation, TLS events Secondary Endpoints: Preliminary antitumor activity |
Part 2: Efficacy expansion |
R/R MCL |
Sonrotoclax |
None |
Primary Endpoint: Part 2: ORR (IRC) Key Secondary Endpoints: ORR (INV), DOR (IRC, INV), PFS (IRC, INV) TTR (IRC, INV), HRQoL, OS, safety |
