Actively Recruiting
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer
Led by Aston Sci. Inc. · Updated on 2024-07-10
24
Participants Needed
6
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this early proof-of-concept study to evaluate the safety and immunologic efficacy of AST-301 in gastric cancer patients with HER2 expression (including both HER2 low expression and overexpression) who have completed the standard adjuvant treatment (including those who discontinued the standard adjuvant treatment due to intolerance). Participants will be randomized 1:1 to either Arm 1 (Q3W, 3 cycles), or Arm 2 (Q3W, 6 cycles) of the study. Safety Monitoring Committee (SMC) will oversee safety of study at 25% (6 participants), 50% (12 participants), and 75% (18 participants) of participants receive at least 1 dose of AST-301 and survival follow up will be performed to determine disease-free survival (DFS).
CONDITIONS
Official Title
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Underwent curative surgery with standard lymph node dissection and no residual tumor (R0 resection)
- Completed standard adjuvant treatment
- Diagnosed with stage II or III gastric cancer according to AJCC 8th edition
- HER2 low expression or overexpression based on CAP/ASCP/ASCO 2016 guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Has adequate organ function
You will not qualify if you...
- History of hypersensitivity or contraindications to rhuGM-CSF
- History of other cancers within 5 years before first study treatment except treated non-melanoma skin cancer or epithelial carcinoma without disease
- Received systemic immunosuppressants within 4 weeks before first study treatment
- History of autoimmune or inflammatory disease
- Active infections including tuberculosis, hepatitis B, hepatitis C, or HIV
- Pregnant, breastfeeding, or expecting to conceive children
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
2
China Medical University Hospital
Taichung, Taiwan, 404
Actively Recruiting
3
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
4
Chi Mei Medical Center
Tainan, Taiwan, 710
Actively Recruiting
5
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
6
Chang Gung Memorial Hospital Linkou
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
H
Hun Jung, MD, PhD
CONTACT
M
Minghua Huang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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