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

A Single-Arm, Multi-Center, Open-Label, Phase 2 Study to Evaluate Efficacy and Safety of Tislelizumab (BGB-A317), an Anti-PD-1 Monoclonal Antibody, as Monotherapy in Patients With Previously-Treated Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors

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).

Study Overview

• Status: Recruiting
• Conditions: MSI-H/dMMR Solid Tumors
• Intervention / Treatment: Drug: Tislelizumab (BGB-A317)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: BeiGene; Phone Number: +1-877-828-5568; Email: clinicaltrials@beigene.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Completed
      • Anhui Provincial Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100142
      • Active, not recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100021
      • Completed
      • Cancer Hospital Chinese Academy of Medical Sciences
    • Beijing, Beijing Municipality, China, 100071
      • Completed
      • The Affiliated Hospital of Military Medical Sciences
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Recruiting
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Active, not recruiting
      • Fujian Medical University Union Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Completed
      • Guangdong Provincial Peoples Hospital
    • Guangzhou, Guangdong, China, 510515
      • Completed
      • Nanfang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510655
      • Completed
      • The Sixth Affiliated Hospital, Sun Yat Sen University
    • Huizhou, Guangdong, China, 516000
      • Recruiting
      • Huizhou First Hospital
    • Meizhou, Guangdong, China, 514031
      • Recruiting
      • Meizhou People Hospital
  • Guangxi
    • Hechi, Guangxi, China, 547099
      • Active, not recruiting
      • The Peoples Hospital of Hechi
  • Hebei
    • Baoding, Hebei, China, 071000
      • Completed
      • Affiliated Hospital of Hebei University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Completed
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Completed
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430079
      • Completed
      • Hubei Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Completed
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Completed
      • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
    • Nanjing, Jiangsu, China, 210029
      • Completed
      • Jiangsu province hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • Completed
      • Jilin Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Completed
      • The General Hospital of Shenyang Military
  • Shandong
    • Weifang, Shandong, China, 262550
      • Completed
      • Yidu Central Hospital of Weifang
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Completed
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai Municipality, China, 200032
      • Completed
      • Affiliated Zhongshan Hospital of Fudan University
  • Sichuan
    • Yibin, Sichuan, China, 644000
      • Active, not recruiting
      • The First Peoples Hospital of Yibin
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Completed
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • Completed
      • The first Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310009
      • Completed
      • Zhejiang University College of Medicine Second Affiliated Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Key Exclusion Criteria:

1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug 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 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug
7. Having a history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, or uncontrolled systemic diseases (including but not limited to diabetes, hypertension, etc.)
8. Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab (BGB-A317) Injection	Drug: Tislelizumab (BGB-A317); Anti-PD-1 Antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	Up to 2 years
Duration of response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1	Up to 2 years
Time to response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1	Up to 2 years
Progression-free survival assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1	Up to 2 years
Disease control rate assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1	Up to 2 years
Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1	Up to 2 years
Safety and tolerability assessment per the number of participants experiencing Treatment-Emergent Adverse Event (TEAE) as assessed by CTCAE v5.0	Up to 2 years

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Principal Investigator: Lin Shen, PHD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Solid tumors; PD-1; MSI-H/dMMR
• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; tislelizumab
• Other Study ID Numbers: BGB-A317-209; CTR20180867 (Registry Identifier: ChinaDrugTrials)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No