Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria
- 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
EXCLUSION CRITERIA
Key Exclusion Criteria
- 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
- Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment
- 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.
- Current or history of central nervous involvement
- 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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
B-cell Malignancy,Non-Hodgkin Lymphoma,Mantle Cell Lymphoma,Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,Waldenström Macroglobulinemia,Marginal Zone Lymphoma,Follicular Lymphoma,DLBCL Unclassifiable,Richter's Transformation
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
127
Est. Completion Date
Sep 30, 2027
Treatment Type
INTERVENTIONAL
Sponsor
BeiGene
ClinicalTrials.gov NCT Identifier
NCT05294731
Study Number
BGB-16673-102
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