A Phase 12, Open-Label, Dose-Escalation and Expansion Study of BGB-16673, a Bruton Tyrosine Kinase Targeted Protein Degrader, in Patients With B-Cell Malignancies

What this Trial Is About

Researchers are evaluating BGB-16673, an orally administered Bruton Tyrosine Kinase targeted protein degrader, in adults with various B-cell malignancies including relapsed or refractory forms of marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemiasmall lymphocytic lymphoma, Waldenstrf6m macroglobulinemia, diffuse large B-cell lymphoma, and Richters transformation. The study aims to find the recommended dose and assess the safety, tolerability, and response rates in this population through a phase 12 open-label trial. The trial includes several parts a phase 1 monotherapy dose finding with dose escalation and safety expansion, followed by phase 2 expansion cohorts. Participants receive BGB-16673 orally at various dose levels to determine the maximum tolerated dose and the recommended dose for further study. Specific groups include Japanese participants and those who have not previously received a Bruton Tyrosine Kinase inhibitor. Dose escalation and safety data are collected to guide dosing recommendations, with some cohorts focused on particular lymphoma subtypes and treatment histories. Participants will be monitored from the first dose of BGB-16673 until 30 days after the last dose or before starting new anticancer therapies, for up to 47 weeks in phase 1 and approximately three years in phase 2. Assessments include adverse event tracking, response rates, pharmacokinetics, and quality of life questionnaires. Various measures such as plasma drug concentration, protein degradation, and progression-free survival are evaluated periodically. Safety and efficacy data support long-term monitoring and dose adjustments throughout the study period.

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies