Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Burton 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, Age ≥ 18 years
- 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
- Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia, small lymphocytic lymphoma, WM, diffuse large B-cell lymphoma (DLBCL) (part 1a only), or Richter's transformation to DLBCL (part 1a only).
- 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, or proton-pimp inhibitors ≤ 14 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’s 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 (in years)
18+
Phase
Phase 1
Participants needed
116
Est. Completion Date
Mar 31, 2027
Treatment type
Interventional
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT05294731
Study number
BGB-16673-102
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