Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
Trial Parameters
Brief Summary
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
Eligibility Criteria
Key Inclusion Criteria 1. Provision of signed and dated written informed consent prior to any study 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria 4. 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 5. Phase 2: Confirmed diagnosis of MCL, or CLL/SLL 6. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug Key Exclusion Criteria 1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma i