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A made-to-order DNA vaccine takes aim at liver cancer's return

NCT ID NCT07722741

Vaccine Sponsor: Geneos Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 23, 2026 · Last updated Sep 04, 2026 · Updated 8 times

Summary

This phase II trial tests whether a personalized DNA vaccine, tailored to each patient's tumor, can keep high-risk liver cancer from coming back after surgical removal. Participants who have no remaining signs of cancer after surgery will receive the vaccine plus an immune booster, or simply be monitored. The goal is to see if the vaccine can train the immune system to recognize and destroy any leftover cancer cells, potentially extending the time without recurrence.

What this could mean

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

Active substance
a personalized neoantigen DNA vaccine (GNOS-PV02) plus a plasmid encoding IL-12 (INO-9012), delivered by injection followed by electroporation
What this could lead to
If successful, this approach could offer a way to prevent liver cancer from coming back after surgery, potentially improving long-term survival.
What could go wrong
This is an early-phase trial with only 90 participants, so results may not apply broadly. The vaccine is personalized, making it complex and costly to produce, and side effects from the vaccine or electroporation are possible.

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

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2032

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 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: 1. Written informed consent 2. ≥18 years of age 3. Histologically or cytologically confirmed diagnosis of HCC (not accepted: fibrolamellar, sarcomatoid, mixed cholangiocarcinoma) 4. Child-Pugh Class A liver score 5. Documented virology status of hepatitis 6. Availability of a representative post-resection tumor tissue sample 7. ECOG performance status of 0 or 1 8. Adequate organ function 9. Women of childbearing potential (WOCBP) and men must be willing to use an adequate method of contraception Exclusion Criteria: 1. Is currently participating in and receiving study drug or has participated in a study of an investigational agent and received study drug or used an investigation device, within 4 weeks to baseline 2. Evidence of residual, recurrent, or metastatic disease at randomization 3. Active or history of autoimmune disease or immune deficiency 4. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug 5. Diagnosed additional malignancy within 5 years prior to baseline, except for: (a) non-invasive carcinomas subject to successful curative treatment in the opinion of the investigator which require no further therapy and (b) other malignancies for which subjects have undergone potentially curative therapy and have been considered disease free for at least 3 years prior to screening. 6. Active infection requiring systemic therapy 7. Is pregnant, breastfeeding or expecting to conceive or father children within the study's projected duration 8. History of human immunodeficiency virus (HIV) (HIV I/II antibodies). 9. Co-infection with HBV and hepatitis D viral infection 10. Co-infection with HBV and HCV 11. Has received a live vaccine within 30 days of planned start of study

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

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

HCC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Auckland City Hospital (Te Toka Tumai)

    RECRUITING

    Auckland, 1023, New Zealand

    Contact Email: •••••@•••••

  • Emory University

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fred Hutchinson Cancer Center

    NOT_YET_RECRUITING

    Seattle, Washington, 98109, United States

    Contact Email: •••••@•••••

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

    Contact Email: •••••@•••••

  • Louisiana State University Health Sciences Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

    Contact Email: •••••@•••••

  • University of Michigan

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

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