A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

Condition studied

Relapsed or Refractory B-Cell Malignancies

Investigational medicinal product(s)

Eligibility

Primary endpoint

Number of patients with dose-limiting toxicities (Part 1a), Number of patients with treatment-emergent adverse events (Part 1a, part 1b), Number of patients with treatment-related adverse events (Part 1a, part 1b), Number of patients with serious adverse events (Part 1a, part 1b)

Endpoint detail

Overall response rate (ORR) as assessed by the investigator (Part 1a, part 1b), Duration of response (DOR) (Part 1a, part 1b), Time-to-response (TTR) (Part 1a, part 1b), Derived PK parameters of BGB-16673 (Part 1a), Plasma concentration data (Part 1a, part 1b), Number of patients with complete response/complete response with incomplete count recovery (CR/CRi) who achieve uMRD status with < 10^(-4) sensitivity in peripheral blood and/or bone marrow (Part 1b, sub-study 1 only), Derived PK parameters of sonrotoclax (Part 1a, sub-study 1 only)