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

Last updated: April 16, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Follicular Lymphoma

Waldenstrom Macroglobulinemia

Treatment

BGB-16673

Clinical Study ID

NCT05294731
BGB-16673-102
CTR20220399
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 146
Treatment Group(s): 1
Primary Treatment: BGB-16673
Phase: 1/2
Study Start date:
May 06, 2022
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233004
    China

    Active - Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui 233004
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • Beijing Chao Yang Hospital

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Beijing Chao Yang Hospital,Capital Medical University

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Sichuan, Chengdu
    China

    Site Not Available

  • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

    Chongqing, Chongqing 400037
    China

    Active - Recruiting

  • Xinqiao Hospital Affiliated to The Army Medical University

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

  • Xinqiao Hospital Affiliated to the Army Medical University

    Chongqing, Chongqing 400037
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • Guangdong Provincial Peoples Hospital Huifu Branch

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Sun Yat- Sen University Cancer Center (Huangpu Campus)

    Guanzhou, Guangdong
    China

    Site Not Available

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • Nanyang Central Hospital

    Nanyang, Henan 473000
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei 441021
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • Jiangxi Province Cancer Hospital

    Nanchang, Jiangxi 330029
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning 116001
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Active - Recruiting

  • Qingdao Central Hospital

    Qingdao, Shandong 266031
    China

    Active - Recruiting

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030013
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine Branch Yuhang

    Hangzhou, Zhejiang 311121
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Zhejiang,
    China

    Site Not Available

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