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Recruiting Phase 1/2 NCT05294731

Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader

Phase 1/2 – combined early trial
Conditions: B-cell Malignancy Non-Hodgkin Lymphoma Mantle Cell Lymphoma Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Waldenström Macroglobulinemia Marginal Zone Lymphoma Follicular Lymphoma DLBCL Unclassifiable Richter's Transformation

Sponsor: BeiGene

trial.available_in: БГ
Overview
This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts
Who can participate
Key Inclusion Criteria 1. Provision of signed and dated written informed consent prior to any study 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 Key Exclusion Criteria 1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply
Interventions
BGB-16673
DRUG
Locations 29
China (29)
Peking University Third Hospital
Beijing , Beijing Municipality
Beijing Chao Yang Hospital,Capital Medical University
Beijing , Beijing Municipality
The First Affiliated Hospital of Bengbu Medical University
Bengbu , Anhui
The First Hospital of Jilin University
Changchun , Jilin
The Second Xiangya Hospital of Central South University
Changsha , Hunan
West China Hospital, Sichuan University
Chengdu , Sichuan
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing , Chongqing Municipality
Affiliated Zhongshan Hospital of Dalian University
Dalian , Liaoning
Fujian Medical University Union Hospital
Fuzhou , Fujian
Sun Yat Sen University Cancer Center
Guangzhou , Guangdong
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou , Guangdong
The First Affiliated Hospital, Zhejiang University School of Medicine Branch Yuhang
Hangzhou , Zhejiang
Anhui Provincial Hospital
Hefei , Anhui
Shandong Cancer Hospital
Jinan , Shandong
First Affiliated Hospital of Kunming Medical University
Kunming , Yunnan
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang , Jiangxi
Jiangxi Province Cancer Hospital
Nanchang , Jiangxi
Jiangsu Province Hospital
Nanjing , Jiangsu
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning , Guangxi
Nanyang Central Hospital
Nanyang , Henan
Qingdao Central Hospital
Qingdao , Shandong
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai , Shanghai Municipality
The First Affiliated Hospital of Soochow University
Suzhou , Jiangsu
Shanxi Provincial Cancer Hospital
Taiyuan , Shanxi
Institute of Hematology and Hospital of Blood Disease
Tianjin , Tianjin Municipality
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , Zhejiang
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan , Hubei
Xiangyang Central Hospital
Xiangyang , Hubei
Henan Cancer Hospital
Zhengzhou , Henan
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.05.2022
Completion date
31.01.2029
Registry ID
NCT05294731
Source
clinicaltrials.gov
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