Treatment of advanced solid tumors with Tislelizumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, single-arm, multi-center, open-label study aims to evaluate the efficacy of Tislelizumab, an anti-PD-1 monoclonal antibody, in patients with locally advanced unresectable or metastatic solid tumors characterized by microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR). Participants must have previously received cancer therapies and have at least one measurable lesion. The study will assess the treatment's impact on tumor response and overall patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Huizhou First Hospital
  Huizhou, Guangdong, China Recruiting
• The Peoples Hospital of Hechi
  Hechi, Guangxi, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• The First Peoples Hospital of Yibin
  Yibin, Sichuan, China Recruiting

Study contacts

• Principal investigator: Lin Shen, PhD — Peking University Cancer Hospital & Institute
• Study coordinator: BeiGene
• Email: clinicaltrials@beigene.com
• Phone: +1-877-828-5568

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.