RecruitingPhase 1Phase 2NCT05294731
Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies
Sponsor
BeiGene
Enrollment
146 participants
Start Date
May 6, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria5
- 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
Interventions
DRUGBGB-16673
Orally administered
Locations(29)
View Full Details on ClinicalTrials.gov
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NCT05294731
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