For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

EXCLUSION CRITERIA

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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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +1-877-828-5568Email iconEmail Study Center

Study Details


Contition

MSI-H/dMMR Solid Tumors

Age

18+

Phase

PHASE2

Participants Needed

200

Est. Completion Date

Sep 30, 2027

Treatment Type

INTERVENTIONAL


Sponsor

BeiGene

ClinicalTrials.gov NCT Identifier

NCT03736889

Study Number

BGB-A317-209

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