China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the first patient dosing in a first-in-human trial for its pipeline candidate, BGB-21447, a next-generation BCL-2 inhibitor. The trial, which is potentially superior to venetoclax based on preclinical activity, is being conducted at Shandong Hospital.
Phase I Study Design and Objectives
The open, dosage escalation Phase I study is assessing BGB-21447 in patients with mature B-cell malignant tumors. The study includes a dose escalation cohort in patients with non-Hodgkin lymphoma (NHL), a dose escalation cohort in patients with low tumor load chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and a dose confirmation cohort in patients with high tumor load CLL/SLL. The primary aim is to evaluate the safety and tolerability of BGB-21447 as a monotherapy and to determine the maximum tolerable dose (or maximum dosage) and Phase II recommended dose for BGB-21447 in patients with NHL and CLL/SLL.
Patient Enrollment and Study Centers
The study is expected to enroll 60 patients across 13 centers in China. This multi-center approach will provide a comprehensive evaluation of the drug’s safety and dosing regimen, contributing to the understanding of BGB-21447’s potential as a treatment for B-cell malignancies.-Fineline Info & Tech
