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

ConditionGastric Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAston Sci. Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AST-301

    Drug

    100 μg

  • rhuGM-CSF

    Drug

    100 μg

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Total 300 μg of AST-301Experimental treatment 2 interventions
Group B: Total 600 μg of AST-301Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 20 weeks
2

Immunologic efficacy of AST-301 immunization

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

Time frame
52 weeks

Secondary outcomes

1

1year Disease-Free Survival rate (DFS rate)

disease free survival rate at 1 year

Time frame
12 months
2

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

disease free survival at end of study

Time frame
Overall study period approximately 31 months
3

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

AST-301-specific IFN γ response by ELISpot assay

Time frame
52 weeks
4

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

Central memory T-cell (cluster of differentiation 4 (CD4) + and cluster of differentiation 8 (CD8) +) by a flow cytometry analysis

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aston Sci. Inc.

Lead sponsor

Source ClinicalTrials.gov
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