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New immunotherapy drug tislelizumab targets Hard-to-Treat cancers

NCT ID NCT03736889

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This Phase 2 trial is testing tislelizumab, an immunotherapy drug, in 200 people with advanced solid tumors that have specific genetic changes (MSI-H or dMMR) and have not responded to prior treatments. The drug works by blocking PD-1, helping the immune system recognize and attack cancer cells. The main goal is to see how many patients' tumors shrink or disappear.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tislelizumab (an immunotherapy drug that helps the immune system attack cancer cells)
What this could lead to
If successful, this could offer a new treatment option for people with advanced cancers that have specific genetic features (MSI-H or dMMR) and have not responded to prior therapies.
What could go wrong
This is a mid-stage (Phase 2) trial with no control group, so results are preliminary. The drug may not work for all tumor types, and side effects from immune activation (e.g., inflammation of organs) are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2018

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Lynch syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Msi-H/DMMR solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Affiliated Hospital of Hebei University

    COMPLETED

    Baoding, Hebei, 071000, China

  • Affiliated Zhongshan Hospital of Fudan University

    COMPLETED

    Shanghai, Shanghai Municipality, 200032, China

  • Anhui Provincial Hospital

    COMPLETED

    Hefei, Anhui, 230000, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Beijing Cancer Hospital

    ACTIVE_NOT_RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    COMPLETED

    Beijing, Beijing Municipality, 100021, China

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • Fudan University Shanghai Cancer Center

    COMPLETED

    Shanghai, Shanghai Municipality, 200000, China

  • Fujian Medical University Union Hospital

    ACTIVE_NOT_RECRUITING

    Fuzhou, Fujian, 350001, China

  • Guangdong Provincial Peoples Hospital

    COMPLETED

    Guangzhou, Guangdong, 510080, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    COMPLETED

    Zhengzhou, Henan, 450000, China

  • Hubei Cancer Hospital

    COMPLETED

    Wuhan, Hubei, 430079, China

  • Huizhou First Hospital

    RECRUITING

    Huizhou, Guangdong, 516000, China

  • Hunan Cancer Hospital

    COMPLETED

    Changsha, Hunan, 410013, China

  • Jiangsu Province Hospital

    COMPLETED

    Nanjing, Jiangsu, 210029, China

  • Jilin Cancer Hospital

    COMPLETED

    Changchun, Jilin, 130021, China

  • Meizhou People Hospital

    RECRUITING

    Meizhou, Guangdong, 514031, China

  • Nanfang Hospital of Southern Medical University

    COMPLETED

    Guangzhou, Guangdong, 510515, China

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

    COMPLETED

    Nanjing, Jiangsu, 210008, China

  • The Affiliated Hospital of Military Medical Sciences

    COMPLETED

    Beijing, Beijing Municipality, 100071, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    COMPLETED

    Hangzhou, Zhejiang, 310003, China

  • The First Peoples Hospital of Yibin

    ACTIVE_NOT_RECRUITING

    Yibin, Sichuan, 644000, China

  • The General Hospital of Shenyang Military

    COMPLETED

    Shenyang, Liaoning, 110016, China

  • The Peoples Hospital of Hechi

    ACTIVE_NOT_RECRUITING

    Hechi, Guangxi, 547099, China

  • The Sixth Affiliated Hospital, Sun Yat Sen University

    COMPLETED

    Guangzhou, Guangdong, 510655, China

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

    COMPLETED

    Wuhan, Hubei, 430030, China

  • Yidu Central Hospital of Weifang

    COMPLETED

    Weifang, Shandong, 262550, China

  • Zhejiang Cancer Hospital

    COMPLETED

    Hangzhou, Zhejiang, 310022, China

  • Zhejiang University College of Medicine Second Affiliated Hospital

    COMPLETED

    Hangzhou, Zhejiang, 310009, China