Phase 1b2 Study of Oral BTK-Degrader BGB-16673 Combined with Other Drugs for Relapsed or Refractory B-Cell Cancers

What this Trial Is About

Researchers are evaluating the safety, early antitumor activity, and how the body processes and responds to BGB-16673 combined with other medicines in people with relapsed or refractory B-cell malignancies. This study is organized as a master protocol with multiple substudies, each testing BGB-16673 with different combination agents such as sonrotoclax, zanubrutinib, mosunetuzumab, and glofitamab. The study may add more substudies as new combination agents are identified. Participants receive BGB-16673 orally along with one of the other study drugs, which are given either orally, subcutaneously, or intravenously depending on the agent. The study includes sequential dose escalation and safety expansion phases for each combination in separate substudies. For example, participants receiving glofitamab will also get obinutuzumab as pretreatment before starting the combination therapy. During the study, participants undergo regular monitoring to assess treatment safety, side effects, and antitumor response up to approximately two years after the last dose. Researchers will measure dose-limiting toxicities, adverse events, response rates, duration and time to response, and drug levels in the body. The total study participation may last up to three years to capture long-term outcomes and drug effects.

A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies