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RECRUITING
NCT05771584
PHASE2

Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer

Sponsor: Aston Sci. Inc.

View on ClinicalTrials.gov

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).

Official title: A Phase 2 Study to Evaluate the Safety and Immunological Efficacy of Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Expressing Gastric Cancer (CORNERSTONE-003)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-07-04

Completion Date

2026-06-15

Last Updated

2024-07-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

AST-301

100 μg

DRUG

rhuGM-CSF

100 μg

Locations (6)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Chi Mei Medical Center

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital Linkou

Taoyuan District, Taiwan