MSI-H/dMMR Solid TumorsPhase 2NCT03736889
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
A Phase 2 study testing Tislelizumab (BGB-A317) in people with MSI-H/dMMR Solid Tumors, run by BeiGene at 29 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MSI-H/dMMR Solid Tumors
- What is being tested?
- Tislelizumab (BGB-A317)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 29 sitesChina
- Study dates
- 19 Sep 2018to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having histological confirmed diagnosis of malignancy
- Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
- Having received prior cancer therapy regimen(s) for advanced disease.
- At least 1 measurable lesion as defined per RECIST Version (v) 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
Who cannot join
- 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
- 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
- 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
Show all 14Show fewer
- 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.)
- Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management
- Having severe chronic or active infections
- A known history of human immunodeficiency virus infection
- Child - Pugh B or greater cirrhosis
- Any major surgical procedure ≤ 28 days before the first dose of study drug
- Prior allogeneic stem cell transplantation or organ transplantation
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
China29 sites, 6 recruiting
- Completed
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
- Completed
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
- Completed
The Affiliated Hospital of Military Medical Sciences
Beijing, Beijing Municipality, 100071
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Active, not recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130021
- Completed
Hunan Cancer Hospital
Changsha, Hunan, 410013
- Active, not recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
- Completed
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080
- Completed
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
- Completed
The Sixth Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, 510655
- Completed
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
- Completed
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009
- Completed
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
- Recruiting
The Peoples Hospital of Hechi
Hechi, Guangxi, 547099
- Completed
Anhui Provincial Hospital
Hefei, Anhui, 230000
- Recruiting
Huizhou First Hospital
Huizhou, Guangdong, 516000
- Active, not recruiting
Meizhou People Hospital
Meizhou, Guangdong, 514031
- Completed
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
- Completed
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
- Completed
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
- Completed
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
- Completed
The General Hospital of Shenyang Military
Shenyang, Liaoning, 110016
- Active, not recruiting
Yidu Central Hospital of Weifang
Weifang, Shandong, 262550
- Completed
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030
- Completed
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Recruiting
The First Peoples Hospital of Yibin
Yibin, Sichuan, 644000
- Completed
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: 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).
- Conditions
- MSI-H/dMMR Solid Tumors
- Being tested
- Tislelizumab (BGB-A317)
- Keywords
- MSI-H/dMMR, Solid tumors, PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab (BGB-A317)Drug
Anti-PD-1 Antibody
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab (BGB-A317) Injection | Experimental | Not described Receives: Drug: Tislelizumab (BGB-A317) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1
Measured: Up to 2 years
Secondary outcomes (7)
Duration of response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 2 years
Overall survival
Measured: Up to 2 years
Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
Measured: 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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start19 Sep 2018
- Primary completionNov 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSI-H/dMMR Solid TumorsStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, PhD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736889
- Sponsor's protocol ID
- BGB-A317-209
- Other IDs
- CTR20180867
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2018
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03736889
- Acronym / sponsor ID
- BGB-A317-209
- Conditions
- MSI-H/dMMR Solid Tumors
- Keywords
- MSI-H/dMMR, Solid tumors, PD-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab (BGB-A317) Injection | Experimental | Drug: Tislelizumab (BGB-A317) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having histological confirmed diagnosis of malignancy
- Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
- Having received prior cancer therapy regimen(s) for advanced disease.
- At least 1 measurable lesion as defined per RECIST Version (v) 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Key exclusion criteria (14 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab (BGB-A317)Anti-PD-1 Antibody | Drug | Tislelizumab (BGB-A317) Injection |
Primary outcome
Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1
Time frame: Up to 2 years
7 secondary outcomes
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
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
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
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
Overall survival
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lin Shen, PhD principal investigator
Peking University Cancer Hospital & Institute
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab (BGB-A317) in people with MSI-H/dMMR Solid Tumors, run by BeiGene at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BeiGene (+1-877-828-5568, clinicaltrials@beigene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1 (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.