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

NCT ID: NCT05771584

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-04
• Study Completion Date: 2026-06-15

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).

Detailed Description

Participants will provide informed consent and will undergo Pre-Screening/Screening procedures before taking part in the study. Participants will be in Arm 1 and Arm 2 will be conducted in parallel. AST-301 will be administrated every 3 weeks for a total of 3 immunizations in Arm 1 and a total of 6 immunizations in Arm 2.

• Arm 1: 3 immunizations of AST-301 admixed with immunoadjuvant recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) administered at 3-week intervals. (Total 300 μg of AST-301)
• Arm 2: 6 immunizations of AST-301 admixed with immunoadjuvant recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) administered at 3-week intervals. (Total 600 μg of AST-301) Randomization will be stratified according to HER2 expression (HER2 low expression or HER2 overexpression).

For both Arm 1 and Arm 2 of the study there will be a Pre-screen period, followed by study periods: a Screening Period (Day -28 to Day -1), a Treatment Period (3 cycles/Arm 1 and 6 cycles/Arm 2), an end of treatment (EOT) visit and follow-up visits.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total 300 μg of AST-301

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

Group Type: EXPERIMENTAL

AST-301

Intervention Type: DRUG

100 μg

rhuGM-CSF

Intervention Type: DRUG

100 μg

Total 600 μg of AST-301

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

Group Type: EXPERIMENTAL

AST-301

Intervention Type: DRUG

100 μg

rhuGM-CSF

Intervention Type: DRUG

100 μg

Interventions

AST-301

100 μg

Intervention Type: DRUG

rhuGM-CSF

100 μg

Intervention Type: DRUG

Other Intervention Names

pNGVL3-hICD; Leukine; Sargramostim

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aston Sci. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hun Jung, MD

Role: STUDY_DIRECTOR

jhun@astonsci.com

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Chi Mei Medical Center

Tainan City, , Taiwan

Site Status: RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Chang Gung Memorial Hospital Linkou

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hun Jung, MD, PhD

Role: CONTACT

jhun@astonsci.com

82-2-2038-2347

Minghua Huang, MD

Role: CONTACT

mhhwang@astonsci.com

82-2-2038-2347

Facility Contacts

I-CHEN WU, MD

Role: primary

LI-YUAN BAI, MD

Role: primary

SHAO-CIAO LUO, MD

Role: primary

YIN-HSUN FENG, MD

Role: primary

MING-HUANG CHEN, MD

Role: primary

WEN-CHI CHOU, MD

Role: primary

Other Identifiers

PN-301-22

Identifier Type: -

Identifier Source: org_study_id