Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies

Mature B-cell Malignancies Clinical Trial

Official title:
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Bcl-2 Inhibitor BGB-11417 in Adult Patients With Mature B-cell Malignancies

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of BGB-11417 monotherapy, define the maximum tolerated dose (MTD) or maximum administered dose and the recommended Phase 2 dose (RP2D) of BGB-11417 monotherapy for the selected B-cell malignancy dose finding cohorts, and evaluate the safety and tolerability of the ramp-up dosing schedule in the evaluated disease types.

Clinical Trial Description

This study will have 3 cohorts for determining a monotherapy MTD and ramp-up schedule: Cohort A, participants with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R NHL); Cohort B, participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with low tumor burden; Cohort C, participants with R/R CLL/SLL with high tumor burden. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04883957
Study type	Interventional
Source	BeiGene
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	July 5, 2021
Completion date	April 2026

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See also
Status	Clinical Trial	Phase
Recruiting	`NCT04277637` - Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies	Phase 1
Active, not recruiting	`NCT04172246` - Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies	Phase 1/Phase 2
Not yet recruiting	`NCT06351527` - Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies	Phase 1