Status:
RECRUITING
Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
Lead Sponsor:
BeiGene
Conditions:
B-cell Malignancy
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 select...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
May 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT05294731
Start Date
May 6 2022
End Date
September 30 2027
Last Update
April 20 2025
Active Locations (29)
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1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233004
2
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
4
Beijing Chao Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100020