RecruitingPhase 2NCT05771584

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

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)

Sponsor

Aston Sci. Inc.

Enrollment

24 participants

Start Date

Jul 4, 2023

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer

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).

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

Underwent a curative surgery with standard lymph node dissection (confirmed with no residual tumor, R0 resection) and have completed standard adjuvant treatment
Has stages II or III according to the 8th edition of the American Joint Committee on Cancer (AJCC)
HER2 low expression and HER2 overexpression diagnosed according to the 2016 College of American Pathologists (CAP)/American Society for Clinical Pathology (ASCP)/American Society of Clinical Oncology (ASCO) guidelines
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Demonstrates adequate organ function.

Exclusion Criteria6

Has a history of hypersensitivity or other contraindications to rhuGM-CSF
Has a history of other malignancies ≤5 years prior to first administration of Investigational Product (IP) except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease.
Has received systemic immunosuppressants or were treated with systemic immunosuppressants ≤4 weeks prior to the first administration of Investigational Product (IP).
Has a history of autoimmune disease or inflammatory disease
Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
Is pregnant or breastfeeding or expecting to conceive children