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

NCT05771584 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PN-301-22
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0.

  To assess the safety of AST-301 administered in gastric cancer patients.

  up to 20 weeks

• Immunologic efficacy of AST-301 immunization

  AST-301 specific interferon (IFN)-gamma enzyme-linked immune absorbent spot (ELISpot) assay

  52 weeks

Secondary Outcomes (4)

• 1year Disease-Free Survival rate (DFS rate)

  12 months

• Disease-Free Survival rate (DFS rate) at end of study (EOS)

  Overall study period approximately 31 months

• Compare immunogenicity of AST-301 between Arm 1 and Arm 2

  52 weeks

• Change in central memory T-cell populations between Arm 1 and Arm 2

  52 weeks

Study Arms (2)

Total 300 μg of AST-301

EXPERIMENTAL

AST-301/rhuGM-CSF (3-week interval, 3 cycles in total)

Drug: AST-301; Drug: rhuGM-CSF

Total 600 μg of AST-301

EXPERIMENTAL

AST-301/rhuGM-CSF (3-week interval, 6 cycles in total)

Drug: AST-301; Drug: rhuGM-CSF

Interventions

AST-301 DRUG

100 μg

Also known as: pNGVL3-hICD

Total 300 μg of AST-301; Total 600 μg of AST-301

rhuGM-CSF DRUG

100 μg

Also known as: Leukine, Sargramostim

Total 300 μg of AST-301; Total 600 μg of AST-301

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aston Sci. Inc.: lead

Study Sites (6)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

Chi Mei Medical Center

Tainan, 710, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Chang Gung Memorial Hospital Linkou

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Hun Jung, MD

  jhun@astonsci.com

  STUDY DIRECTOR

Central Study Contacts

Hun Jung, MD, PhD

CONTACT

82-2-2038-2347; jhun@astonsci.com

Minghua Huang, MD

CONTACT

82-2-2038-2347; mhhwang@astonsci.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2, open label, randomized, early proof-of-concept study

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: March 16, 2023
• Study Start: July 4, 2023
• Primary Completion: October 15, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)