drugset / Trial / NCT05828589

A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies

NCT05828589

Phase 1 Terminated 51 enrolled BeOne Medicines
RandomizedSequentialOpen-labelTreatment

Summary

This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Optimization."

Timeline

Start
2023-06-20
Primary completion
2026-06-08
Completion
2026-06-08

Drugs

EvaluationDrugModalityDoseRoute
Subject BGB-21447 Unknown Oral