A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies
This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts
• Provision of signed and dated written informed consent prior to any study
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
• Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria
• Phase 1: Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL/SLL
• Phase 2: Confirmed diagnosis of MCL, or CLL/SLL
• Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug