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

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

NCT ID: NCT05771584

Condition: Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms
Sargramostim

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Phase 2, open label, randomized, early proof-of-concept study

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: AST-301
Description: 100 μg
Arm group label: Total 300 μg of AST-301
Arm group label: Total 600 μg of AST-301

Other name: pNGVL3-hICD

Intervention type: Drug
Intervention name: rhuGM-CSF
Description: 100 μg
Arm group label: Total 300 μg of AST-301
Arm group label: Total 600 μg of AST-301

Other name: Leukine

Other name: Sargramostim

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.

Criteria for eligibility:
Criteria:
Key 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. Key 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

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital

Address:
City: Kaohsiung
Zip: 80756
Country: Taiwan

Status: Recruiting

Contact:
Last name: I-CHEN WU, MD

Facility:
Name: China Medical University Hospital

Address:
City: Taichung
Zip: 404
Country: Taiwan

Status: Recruiting

Contact:
Last name: LI-YUAN BAI, MD

Facility:
Name: Taichung Veterans General Hospital

Address:
City: Taichung
Zip: 40705
Country: Taiwan

Status: Recruiting

Contact:
Last name: SHAO-CIAO LUO, MD

Facility:
Name: Chi Mei Medical Center

Address:
City: Tainan
Zip: 710
Country: Taiwan

Status: Recruiting

Contact:
Last name: YIN-HSUN FENG, MD

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei
Zip: 112
Country: Taiwan

Status: Recruiting

Contact:
Last name: MING-HUANG CHEN, MD

Facility:
Name: Chang Gung Memorial Hospital Linkou

Address:
City: Taoyuan
Zip: 333
Country: Taiwan

Status: Recruiting

Contact:
Last name: WEN-CHI CHOU, MD

Start date: July 4, 2023

Completion date: June 15, 2026

Lead sponsor:
Agency: Aston Sci. Inc.
Agency class: Industry

Source: Aston Sci. Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05771584