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Recruiting Phase 2 NCT03736889

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

Phase 2 – studying effectiveness and dosage
Conditions: MSI-H/dMMR Solid Tumors

Sponsor: BeiGene

trial.available_in: БГ
Overview
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).
Who can participate
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.
Interventions
Tislelizumab (BGB-A317)
DRUG
Locations 29
China (29)
Affiliated Hospital of Hebei University
Baoding , Hebei
COMPLETED
Cancer Hospital Chinese Academy of Medical Sciences
Beijing , Beijing Municipality
COMPLETED
The Affiliated Hospital of Military Medical Sciences
Beijing , Beijing Municipality
COMPLETED
Beijing Cancer Hospital
Beijing , Beijing Municipality
Jilin Cancer Hospital
Changchun , Jilin
COMPLETED
Hunan Cancer Hospital
Changsha , Hunan
COMPLETED
Chongqing University Cancer Hospital
Chongqing , Chongqing Municipality
Fujian Medical University Union Hospital
Fuzhou , Fujian
Guangdong Provincial Peoples Hospital
Guangzhou , Guangdong
COMPLETED
Nanfang Hospital of Southern Medical University
Guangzhou , Guangdong
COMPLETED
The Sixth Affiliated Hospital, Sun Yat Sen University
Guangzhou , Guangdong
COMPLETED
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou , Zhejiang
COMPLETED
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou , Zhejiang
COMPLETED
Zhejiang Cancer Hospital
Hangzhou , Zhejiang
COMPLETED
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
The Peoples Hospital of Hechi
Hechi , Guangxi
Anhui Provincial Hospital
Hefei , Anhui
COMPLETED
Huizhou First Hospital
Huizhou , Guangdong
Meizhou People Hospital
Meizhou , Guangdong
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing , Jiangsu
COMPLETED
Jiangsu Province Hospital
Nanjing , Jiangsu
COMPLETED
Fudan University Shanghai Cancer Center
Shanghai , Shanghai Municipality
COMPLETED
Affiliated Zhongshan Hospital of Fudan University
Shanghai , Shanghai Municipality
COMPLETED
The General Hospital of Shenyang Military
Shenyang , Liaoning
COMPLETED
Yidu Central Hospital of Weifang
Weifang , Shandong
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan , Hubei
COMPLETED
Hubei Cancer Hospital
Wuhan , Hubei
COMPLETED
The First Peoples Hospital of Yibin
Yibin , Sichuan
Henan Cancer Hospital
Zhengzhou , Henan
COMPLETED
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
19.09.2018
Completion date
01.09.2027
Registry ID
NCT03736889
Source
clinicaltrials.gov
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