Study of BGB-16673 for B-Cell Malignancies
This study is testing a new oral medication called BGB-16673 for people with certain B-cell malignancies (cancers that affect a type of white blood cell). These include Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, and Waldenström Macroglobulinemia. The study aims to find the safest and most effective dose of BGB-16673. Researchers will look at side effects and how well the drug is tolerated. The study is open to adults aged 18 and older who have a confirmed diagnosis of one of the listed B-cell malignancies. BGB-16673 works by targeting tyrosine kinase, a mechanism involved in cancer growth.
- Study design
- This study is designed in two main parts: a dose-finding phase and an expansion phase, involving up to 645 participants. It is an interventional study, meaning participants will receive the study drug.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events from the first dose until 30 days after the last dose or before starting new anti-cancer therapy, up to 47 weeks. Recommended doses for expansion will be determined over approximately 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies
At a glance
Conditions
Where it's being run
115 sites across 50 statesStudy leadership
- Study Director · STUDY_DIRECTOR · BeOne Medicines
Who to contact
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What this trial measures
- Phase 1: Number of Participants with Adverse Events (AEs)From the first dose of tacabrutideg until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks)
Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) including results from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicities (DLTs); as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
- Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of TacabrutidegApproximately 28 days
MTD is defined as the highest evaluated dose with an estimated toxicity rate closest to the target, while MAD is the highest dose given if MTD is not reached.
- Phase 1: Recommended dose(s) for Expansion (RDFE) of tacabrutidegApproximately 3 years
RDFE of tacabrutideg alone will be determined based upon the MTD or MAD.
- Phase 2: Overall response rate (ORR)approximately 3 years
Defined as the percentage of participants achieving a best overall response of partial response (PR) or better, assessed by the Independent Review Committee for participants with R/R CLL/SLL and R/R WM (in participants with WM, this is also referred to as major response rate) and by the investigator for other cohorts (R/R MCL, R/R MZL, R/R FL, R/R non-GCB DLBCL, R/R Richter's transformation to DLBCL), evaluated using the Lugano criteria for NHL and SLL, International Workshop of Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL, and the 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM-11) criteria for WM.