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Can a cancer vaccine train the body to fight advanced tumors?

NCT ID NCT04864418

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 trial is testing an experimental therapeutic cancer vaccine called AST-021p in people with advanced solid tumors that no longer respond to standard treatments. The goal is to see if the vaccine is safe and can trigger an immune response against the cancer. Participants receive a series of injections at different dose levels to find the best and safest dose.

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-021p
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early phase 1 trial with only 22 participants, focused on safety and dosing. It is too soon to know if the vaccine will shrink tumors or improve survival.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

22 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 2024

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

19 years and older

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.

Inclusion Criteria: * has recurrent or metastatic solid cancer that has been proven histologically or cytologically and cannot be treated with surgery or radiotherapy for the purpos of complete remission * does not have a standard treatment that can be applied clinically according to the investigator's judgment * has an expected life expectancy of more than 3 months * adults aged 19 or older based on screening day * ECOG performance status : 0\~1 Exclusion Criteria: * Has a history of hypersensitivity or other contraindications to rhGM-CSF and Montanide ISA 51 VG * Has a history of other primary malignant tumor * Has autoimmune diseases or inflammatory diseases * Has a history of active primary immunodeficiency 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 * has a history of immune suppression therapy ≤4 weeks prior to the screening day

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

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

Advanced cancer

Contacts and locations

Locations

  • Korea University Anam Hospital

    Seoul, South Korea

  • Korea University Guro Hospital

    Seoul, South Korea

  • Seoul ST. Mary's Hospital

    Seoul, South Korea

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