Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
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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.
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
Actual Study Start Date :
September 19, 2018
Estimated Primary Completion Date :
Estimated Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
Having histological confirmed diagnosis of malignancy
Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
Having received or refused 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
Key Exclusion Criteria:
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
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.