Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors

Last updated: December 4, 2024
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Treatment

Tislelizumab (BGB-A317)

Clinical Study ID

NCT03736889
BGB-A317-209
CTR20180867
  • Ages > 18
  • All Genders

Study Summary

In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) will be treated with anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Having histological confirmed diagnosis of malignancy

  2. Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR

  3. Having received prior cancer therapy regimen(s) for advanced disease.

  4. At least 1 measurable lesion as defined per RECIST Version (v) 1.1

  5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

  6. Adequate organ function

Exclusion

Key Exclusion Criteria:

  1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody ordrug specifically targeting T-cell co-stimulation or checkpoint pathways

  2. Active leptomeningeal disease or uncontrolled brain metastasis.

  3. Clinically significant pleural effusion, pericardial effusion or ascites

  4. Active autoimmune diseases or history of autoimmune diseases that may relapse

  5. Any active malignancy

  6. Any condition that required systemic treatment with either corticosteroids (> 10 mgdaily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 daysbefore the first dose of study drug

  7. Having a history of interstitial lung disease, non-infectious pneumonitis, pulmonaryfibrosis, acute lung diseases, or uncontrolled systemic diseases (including but notlimited to diabetes, hypertension, etc.)

  8. Participants with uncontrolled diabetes or uncontrolled electrolyte disordersdespite standard medical management

  9. Having severe chronic or active infections

  10. A known history of human immunodeficiency virus infection

  11. Child - Pugh B or greater cirrhosis

  12. Any major surgical procedure ≤ 28 days before the first dose of study drug

  13. Prior allogeneic stem cell transplantation or organ transplantation

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Tislelizumab (BGB-A317)
Phase: 2
Study Start date:
September 19, 2018
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Completed

  • The Affiliated Hospital of Military Medical Sciences

    Beijing, Beijing 100071
    China

    Completed

  • Chongqing Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian 350025
    China

    Site Not Available

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong 510080
    China

    Completed

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Completed

  • The Sixth Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong 510655
    China

    Completed

  • Huizhou First Hospital

    Huizhou, Guangdong 516000
    China

    Active - Recruiting

  • Meizhou Hospital Affiliated to Sun Yat Sen University

    Meizhou, Guangdong 514031
    China

    Site Not Available

  • Meizhou People Hospital

    Meizhou, Guangdong 514031
    China

    Active - Recruiting

  • The Peoples Hospital of Hechi

    Hechi, Guangxi 547099
    China

    Active - Recruiting

  • Affiliated Hospital of Hebei University

    Baoding, Hebei 071000
    China

    Active - Recruiting

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei 067020
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Completed

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

    Wuhan, Hubei 430030
    China

    Completed

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Completed

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Completed

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Completed

  • Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University

    Ganzhou, Jiangxi 341000
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • The General Hospital of Shenyang Military

    Shenyang, Liaoning 110016
    China

    Completed

  • Yidu Central Hospital of Weifang

    Weifang, Shandong 262550
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200000
    China

    Completed

  • The First Peoples Hospital of Yibin

    Yibin, Sichuan 644000
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Completed

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Completed

  • Zhejiang University College of Medicine Second Affiliated Hospital

    Hangzhou, Zhejiang 310009
    China

    Completed

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