OncoMatch/Clinical Trials/NCT05771584
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer
Is NCT05771584 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including AST-301 and rhuGM-CSF for gastric cancer.
Treatment: AST-301 · rhuGM-CSF — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) low expression (low)
Required: HER2 (ERBB2) overexpression (overexpression)
Disease stage
Required: Stage II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: curative surgery
Underwent a curative surgery with standard lymph node dissection (confirmed with no residual tumor, R0 resection)
Must have received: standard adjuvant treatment
have completed standard adjuvant treatment
Lab requirements
Blood counts
Kidney function
Liver function
Demonstrates adequate organ function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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