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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.

Phase 2RecruitingAston Sci. Inc.NCT05771584Data as of May 2026

Treatment: AST-301 · rhuGM-CSFThe 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).

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Extracted 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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