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

July 9, 2026 updated by: BeiGene

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tislelizumab (BGB-A317) Injection
Drug: Tislelizumab (BGB-A317)
Anti-PD-1 Antibody

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
Up to 2 years
Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeiGene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lin Shen, PHD, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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