Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader

Launched by BEIGENE · Mar 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BGB-16673 for patients with certain types of B-cell cancers, including Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. The goal is to find the best dose of this drug and to see how safe it is, as well as how well it works to shrink tumors. The trial is currently looking for participants who are 65 years and older, and it welcomes both men and women. To join, patients must have a confirmed diagnosis of a specific type of B-cell cancer and be in generally good health.

Participants in this study can expect to receive the treatment alone, without any additional therapies, and will be monitored closely for side effects and treatment effectiveness. It's important to note that there are certain criteria that may prevent someone from participating, such as having had another cancer recently, needing other treatments, or previous stem cell transplants. Overall, this trial offers a potential new option for those with B-cell malignancies who may not have many other treatment choices.

Gender

ALL

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 in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
• • 2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment
• • 3. Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.
• • 4. Current or history of central nervous involvement
• • 5. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply