Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
Study Details
Study Description
Brief 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). Efficacy and safety will be assessed. A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Tislelizumab (BGB-A317) Injection
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Drug: Tislelizumab (BGB-A317)
Anti-PD-1 Antibody
|
Outcome Measures
Primary Outcome Measures
- Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1 [Up to 2 years]
Secondary Outcome Measures
- : Duration of response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [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 [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 [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 [Up to 2 years]
- Overall survival [Up to 2 years]
- Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [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 [Up to 2 years]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Having histological confirmed diagnosis of malignancy
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Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
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Having received or refused prior cancer therapy regimen(s) for advanced disease.
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At least 1 measurable lesion as defined per RECIST Version (v) 1.1
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Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
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Adequate organ function
Key Exclusion Criteria:
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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
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Active leptomeningeal disease or uncontrolled brain metastasis.
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Clinically significant pleural effusion, pericardial effusion or ascites
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Active autoimmune diseases or history of autoimmune diseases that may relapse
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Any active malignancy
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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
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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.)
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Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management
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Having severe chronic or active infections
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A known history of human immunodeficiency virus infection
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Child - Pugh B or greater cirrhosis
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Any major surgical procedure ≤ 28 days before the first dose of study drug
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Prior allogeneic stem cell transplantation or organ transplantation
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Beijing Cancer Hospital | Beijing | Beijing | China | 100142 |
Sponsors and Collaborators
- BeiGene
Investigators
- Principal Investigator: Lin Shen, PhD, Peking University Cancer Hospital & Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BGB-A317-209
- CTR20180867