Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer
Status:
Not yet recruiting
Trial end date:
2026-06-15
Target enrollment:
Participant gender:
Summary
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).