Actively Recruiting
A Phase 1/2 Dose-Escalation and Expansion Study of BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader, in Chinese Patients With B-Cell Malignancies
Led by BeiGene · Updated on 2026-04-17
146
Participants Needed
29
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the recommended phase 2 dose and assess the safety, tolerability, and early antitumor effects of BGB-16673, a Bruton Tyrosine Kinase-targeted protein degrader, in Chinese patients with various B-cell malignancies. The study focuses on specific lymphoma and leukemia types, including mantle cell lymphoma and chronic lymphocytic leukemia, to evaluate this novel oral drug's potential in these conditions. Participants will receive BGB-16673 orally in different study phases. In Phase 1a, dose escalation will determine the maximum tolerated dose and recommended phase 2 dose over about 37 weeks. Phase 1b includes a safety expansion, while Phase 2 focuses on dose expansion at the recommended dose. The study is open-label and involves randomized assignments to monitor effects in multiple B-cell cancer subtypes. Throughout the study, participants will be closely observed for adverse events, overall response rates, and specific blood protein levels related to the drug's effect. Pharmacokinetic measures such as drug concentration and clearance will be monitored at various time points. Patient well-being and symptom changes will be assessed using cancer symptom indexes and quality-of-life questionnaires over approximately three years, with safety follow-up continuing for 30 days after treatment ends.
CONDITIONS
Brief Title
Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent before any study procedures
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function including coagulation, liver, kidney, and pancreas
- For Phase 1: Confirmed diagnosis of relapsed/refractory Marginal Zone Lymphoma, Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia, non-germinal center B-cell diffuse large B-cell lymphoma, Richter's transformation, mantle cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma
- For Phase 2: Confirmed diagnosis of mantle cell lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma
- Use of highly effective birth control during treatment and for at least 90 days after last dose
You will not qualify if you...
- Prior malignancy other than the study disease within 2 years, except certain treated skin, bladder, cervical, breast, or low-risk prostate cancers
- Need for ongoing systemic treatment for other malignancies or systemic corticosteroids
- Use of strong CYP3A inhibitors or inducers within 14 days before first dose, or proton-pump inhibitors within 5 days before first dose
- Current or history of central nervous system involvement
- Prior autologous stem cell transplant less than 3 months ago, prior chimeric cell therapy less than 6 months ago, or prior allogeneic stem cell transplant less than 6 months before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive oral administration of BGB-16673 as part of dose escalation, safety expansion, or dose expansion to treat B-cell malignancies.
Visits occur at baseline, Week 1, Week 5, Week 9, and periodically thereafter for dosing and assessments
Duration - Up to 30 days after last dose
Participants are monitored for adverse events and treatment response for up to 30 days after the last dose or until initiation of new anticancer therapy.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 29 locations
1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233004
Actively Recruiting
2
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
4
Beijing Chao Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
5
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, Chongqing Municipality, China, 400037
Actively Recruiting
6
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
7
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
8
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, China, 510120
Actively Recruiting
9
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530021
Actively Recruiting
10
Nanyang Central Hospital
Nanyang, Henan, China, 473000
Actively Recruiting
11
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
12
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
13
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441021
Actively Recruiting
14
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
15
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
16
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
17
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China, 330006
Actively Recruiting
18
Jiangxi Province Cancer Hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
19
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
20
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China, 116001
Actively Recruiting
21
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
22
Qingdao Central Hospital
Qingdao, Shandong, China, 266031
Actively Recruiting
23
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
24
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 030013
Actively Recruiting
25
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
26
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
27
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
28
The First Affiliated Hospital, Zhejiang University School of Medicine Branch Yuhang
Hangzhou, Zhejiang, China, 311121
Actively Recruiting
29
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
B
BeiGene
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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