A Phase 1/1b Open-Label Dose-Escalation and Dose-Optimization Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Confirmed diagnosis (per World Health Organization \[WHO\] guidelines, unless otherwise noted) of one of the following:
• Cohort A1 and Cohort A2:
⁃ R/R DLBCL (for Cohort A1 and Cohort A2.1)
‣ High-grade B-cell lymphomas with translocations of MYC and Bcl-2 and/or Bcl-6 are not allowed in Cohort A1 but may be allowed in Cohort A2.1
⁃ R/R FL (for Cohort A1 and Cohort A2.2)
⁃ R/R MZL (for Cohort A1 and Cohort A2.2)
⁃ Transformed B-cell NHL (for Cohort A1 only)
⁃ Richter's transformation to DLBCL (for Cohort A1 only)
• Measurable disease by computed tomography/magnetic resonance imaging.
Locations
United States
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Mission Cancer and Blood
RECRUITING
Waukee
Maryland
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
NOT_YET_RECRUITING
Baltimore
New York
Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
NOT_YET_RECRUITING
Mineola
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health
NOT_YET_RECRUITING
New York
Pennsylvania
Thomas Jefferson University
NOT_YET_RECRUITING
Philadelphia
South Dakota
Avera Cancer Institute
RECRUITING
Sioux Falls
Other Locations
Australia
Pindara Private Hospital
RECRUITING
Benowa
Blacktown Cancer and Haematology Centre
RECRUITING
Blacktown
Monash Health
RECRUITING
Clayton
Linear Clinical Research
RECRUITING
Nedlands
Mater Cancer Care Centre
NOT_YET_RECRUITING
South Brisbane
China
Peking University Third Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The First Peoples Hospital of Changzhou
NOT_YET_RECRUITING
Changzhou
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Shandong Provincial Hospital
RECRUITING
Jinan
Linyi Peoples Hospital
COMPLETED
Linyi
The First Affiliated Hospital of Nanchang University Branch Donghu
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University Branch Xianghu
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
Affiliated Zhongshan Hospital of Fudan University
RECRUITING
Shanghai
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Institute of Hematology and Hospital of Blood Disease
RECRUITING
Tianjin
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Experimental: Part 1 (Cohort A1): Dose escalation in patients with B-cell non-Hodgkin lymphoma (NHL)
Participants with R/R B-cell NHL (including diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], marginal zone lymphoma \[MZL\], transformed B-cell NHL (B-NHL), and Richter's transformation to DLBCL) will receive BGB-21447 once a day.
Experimental: Part 1 (Cohort B): Dose escalation in R/R CLL/SLL participants with low tumor burden
Participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) will receive BGB-21447 once a day.
Experimental: Part 2 (Cohort A2.1): BGB-21447 Monotherapy Dose Optimization in R/R DLBCL
Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy.
Experimental: Part 2 (Cohort A2.2): BGB-21447 Monotherapy Dose Optimization in R/R FL or R/R MZL
Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy.