Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
NCT ID: NCT05294731
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
146 participants
INTERVENTIONAL
2022-05-06
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1a Monotherapy Dose Escalation
BGB-16673 will be orally administered.
BGB-16673
Orally administered
Phase 1b Monotherapy Safety Expansion
BGB-16673 will be orally administered.
BGB-16673
Orally administered
Phase 2 Monotherapy Dose Expansion
BGB-16673 will be administered at the recommended Phase 2 dose (RP2D) that was identified in Part 1.
BGB-16673
Orally administered
Interventions
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BGB-16673
Orally administered
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria
4. Phase 1: Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL/SLL
5. Phase 2: Confirmed diagnosis of MCL, or CLL/SLL
6. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug
Exclusion Criteria
2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment
3. Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.
4. Current or history of central nervous involvement
5. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Chao Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Nanyang Central Hospital
Nanyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Jiangxi Province Cancer Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Qingdao Central Hospital
Qingdao, Shandong, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine Branch Yuhang
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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CTR20220399
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-16673-102
Identifier Type: -
Identifier Source: org_study_id
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