Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer (Conerstone3)
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Key Inclusion Criteria: Underwent a curative surgery with standard lymph node dissection (confirmed with no residual tumor, R0 resection) and have completed standard adjuvant treatment Has stages II or III according to the 8th edition of the American Joint Committee on Cancer (AJCC) HER2 low expression and HER2 overexpression diagnosed according to the 2016 College of American Pathologists (CAP)/American Society for Clinical Pathology (ASCP)/American Society of Clinical Oncology (ASCO) guidelines Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Demonstrates adequate organ function. Key Exclusion Criteria: Has a history of hypersensitivity or other contraindications to rhuGM-CSF Has a history of other malignancies ≤5 years prior to first administration of Investigational Product (IP) except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease. Has received systemic immunosuppressants or were treated with systemic immunosuppressants ≤4 weeks prior to the first administration of Investigational Product (IP). Has a history of autoimmune disease or inflammatory disease Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection Is pregnant or breastfeeding or expecting to conceive children
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- China Medical University HospitalRecruiting
- Taichung Veterans General Hospital
- Chi Mei Medical Center
- Taipei Veterans General HospitalRecruiting
- Chang Gung Memorial Hospital Linkou
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Total 300 μg of AST-301
Total 600 μg of AST-301
AST-301/rhuGM-CSF (3-week interval, 3 cycles in total)
AST-301/rhuGM-CSF (3-week interval, 6 cycles in total)