Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT03736889

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

Led by BeiGene · Updated on 2026-04-22

200

Participants Needed

29

Research Sites

467 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of malignancy
  • Locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
  • Prior cancer therapy regimen(s) for advanced disease received
  • At least 1 measurable lesion per RECIST Version 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell co-stimulation/checkpoint pathway targeting drugs
  • Active leptomeningeal disease or uncontrolled brain metastasis
  • Clinically significant pleural effusion, pericardial effusion, or ascites
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • Any active malignancy
  • Systemic corticosteroids (>10 mg prednisone daily or equivalent) or immunosuppressive medication use within 14 days before study drug
  • History of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, or uncontrolled systemic diseases
  • Uncontrolled diabetes or uncontrolled electrolyte disorders despite standard management
  • Severe chronic or active infections
  • Known HIV infection
  • Child-Pugh B or greater cirrhosis
  • Major surgery within 28 days before first dose
  • Prior allogeneic stem cell or organ transplantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 29 locations

1

Anhui Provincial Hospital

Hefei, Anhui, China, 230000

Completed

2

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Completed

3

The Affiliated Hospital of Military Medical Sciences

Beijing, Beijing Municipality, China, 100071

Completed

4

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

5

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

Actively Recruiting

6

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

7

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China, 510080

Completed

8

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510515

Completed

9

The Sixth Affiliated Hospital, Sun Yat Sen University

Guangzhou, Guangdong, China, 510655

Completed

10

Huizhou First Hospital

Huizhou, Guangdong, China, 516000

Actively Recruiting

11

Meizhou People Hospital

Meizhou, Guangdong, China, 514031

Actively Recruiting

12

The Peoples Hospital of Hechi

Hechi, Guangxi, China, 547099

Actively Recruiting

13

Affiliated Hospital of Hebei University

Baoding, Hebei, China, 071000

Completed

14

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150000

Actively Recruiting

15

Henan Cancer Hospital

Zhengzhou, Henan, China, 450000

Completed

16

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

Wuhan, Hubei, China, 430030

Completed

17

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

Completed

18

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

Completed

19

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

Nanjing, Jiangsu, China, 210008

Completed

20

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

Completed

21

Jilin Cancer Hospital

Changchun, Jilin, China, 130021

Completed

22

The General Hospital of Shenyang Military

Shenyang, Liaoning, China, 110016

Completed

23

Yidu Central Hospital of Weifang

Weifang, Shandong, China, 262550

Actively Recruiting

24

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200000

Completed

25

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200032

Completed

26

The First Peoples Hospital of Yibin

Yibin, Sichuan, China, 644000

Actively Recruiting

27

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

Completed

28

Zhejiang University College of Medicine Second Affiliated Hospital

Hangzhou, Zhejiang, China, 310009

Completed

29

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Completed

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Research Team

B

BeiGene

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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