Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kina… (NCT05294731) | Clinical Trial Compass
RecruitingPhase 1/2
Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
China146 participantsStarted 2022-05-06
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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
✕. 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
What they're measuring
1
Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years)
2
Phase 1: Recommended Phase 2 dose (RP2D) of BGB-16673
Timeframe: From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)
3
Phase 1a: Maximum tolerated dose (MTD) of BGB-16673
Timeframe: From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)
4
Phase 2: Overall Response Rate (ORR) in participants with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)
Timeframe: Up to approximately 3 years
5
Phase 2: ORR in participants with R/R Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
✕. 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