Can a DNA vaccine train the immune system to hunt down HER3-Positive cancers?

NCT ID NCT03832855

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This phase 1 trial tests an investigational DNA vaccine called pING-hHER3FL in people whose solid tumors have been surgically removed. The vaccine carries the genetic code for the HER3 protein, which is found on many cancer types, and aims to trigger a targeted immune response against any remaining cancer cells. Participants receive three injections, four weeks apart. Researchers will measure the vaccine's safety and whether it activates HER3-specific T and B cells, with the hope of preventing cancer relapse.

What this could mean

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

Active substance
pING-hHER3FL, an investigational DNA vaccine that produces the HER3 protein to train the immune system against HER3-expressing cancers
What this could lead to
If it works, this vaccine could help prevent cancer from returning after surgery by teaching the immune system to recognize and attack HER3-positive tumors.
What could go wrong
This is an early phase 1 trial with only 10 participants, so safety and immune response are the main goals, not proof of effectiveness. The vaccine may not produce a strong immune response or prevent relapse.

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

10 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Documented history of solid tumor where HER3 expression is expected (this includes breast, colon, lung, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, liver, and esophageal cancer, but other tumors will be considered based on emerging HER3 expression data in the literature). Demonstration of HER3 expression is not required for enrollment. * Has undergone surgical resection of malignancy and has completed intended standard course of chemotherapy and HER2 targeted therapy and radiotherapy under the direction of their physician. Subjects may continue on adjuvant hormonal therapy. * Has no evidence of disease by standard imaging studies (performed at the direction of their physician) within 60 days prior to initiating study treatment. * Between 3 weeks and 2 years since prior cytotoxic chemotherapy, HER2-targeted therapy or radiotherapy to the start of study treatment. * ECOG 0 or 1 * Estimated life expectancy \> 3 months. * Age ≥ 18 years. * Adequate hematologic function, with ANC \>1500/µL, Hemoglobin ≥ 9 g/dL, and Platelets ≥ 75,000/µL. * Adequate renal and hepatic function, with Serum Creatinine \< 1.5 mg/dL, Bilirubin \< 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x ULN or if liver metastases are present \< 5 x ULN. * Female patients must be of non-child-bearing potential or use effective contraception, . * Labs performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within 4 weeks of the start of study treatment. * Ability to understand and provide signed informed consent. * Ability to return to the study site for adequate follow-up, as required by this protocol. * Negative serum pregnancy test within 7 days prior to the start of study treatment, for women of childbearing potential only. Exclusion Criteria: * Patients must have recovered to Grade 1 toxicities from any prior treatment(s). * Known CNS/brain metastases * History of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. * Serious chronic or acute illness considered by the Principal Investigator to constitute an unwarranted high risk for investigational treatment. * Medical or psychological impediment to probable compliance with the protocol. * Concurrent or prior second malignancy (within the past 5 years) other than non-melanoma skin cancer, Carcinoma in situ of the bladder and cervix. * Presence of active infection or systemic use of antimicrobials within 48 hours prior to the start of study treatment. * Patients on continuous steroid therapy for at least 72 hours (or other continuous immunosuppressives such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression. * Presence of a known active acute or chronic infection including HIV or viral hepatitis (Hepatitis B and C). * Pregnant or nursing women. * Prior immunotherapy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

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