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ACTIVE NOT RECRUITING
NCT04883957
PHASE1

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

Sponsor: BeiGene

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2021-07-05

Completion Date

2026-04

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

DRUG

BGB-11417

Film-coated tablets administered orally as specified in the treatment arm.

Locations (11)

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

Shenzhen Peoples Hospital

Shenzhen, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China