drugset / Trial / NCT05828589
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BGB-21447 | Unknown | — | Oral |