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Can a vaccine stop stomach cancer from coming back?

NCT ID NCT05771584

Cure Sponsor: Aston Sci. Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether a therapeutic cancer vaccine called AST-301 can safely train the immune system to fight HER2-expressing gastric cancer cells. The study enrolls people with stage II or III gastric cancer who have already had surgery and completed standard adjuvant treatment. Participants receive the vaccine plus an immune booster in either 3 or 6 doses, and researchers will monitor for side effects and immune responses, as well as how long participants remain cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a therapeutic cancer vaccine called AST-301 (pNGVL3-hICD) plus an immune booster (sargramostim)
What this could lead to
If successful, this vaccine could train the immune system to recognize and destroy leftover cancer cells, potentially preventing gastric cancer from coming back after surgery and standard therapy.
What could go wrong
This is an early proof-of-concept trial with only 24 participants, so results may not apply broadly. The vaccine may cause side effects or fail to trigger a strong enough immune response to prevent recurrence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Jul 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer

Contacts and locations

Locations

  • Chang Gung Memorial Hospital Linkou

    Taoyuan, 333, Taiwan

  • Chi Mei Medical Center

    Tainan, 710, Taiwan

  • China Medical University Hospital

    Taichung, 404, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

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