Spots Global Cancer Trial Database for Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies
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Trial Identification
Brief Title: Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies
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
Study ID: NCT04883957
Conditions
Interventions
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University First Hospital, Beijing, Beijing, China
Peking University Peoples Hospital, Beijing, Beijing, China
Sun Yat Sen University Cancer Center, Guangzhou, 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, China
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Contact Details
Name: Lu Zhang, M.D.
Affiliation: BeiGene (Suzhou) Co., Ltd.
Role: STUDY_DIRECTOR
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