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New PET tracer aims to illuminate hidden HER2 tumors

NCT ID NCT06828588

Diagnosis Sponsor: Vanderbilt-Ingram Cancer Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tests a radioactive tracer called [68Ga]Ga-ABY-025 for PET scans in 30 adults with advanced HER2-positive cancers (breast, gastric, head/neck, esophageal). Participants receive the tracer and a PET/CT scan before or during standard HER2-targeted therapy. The goal is to see if the tracer safely and clearly highlights tumors, potentially improving how doctors track these cancers.

What this could mean

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

Active substance
[68Ga]Ga-ABY-025 (a radioactive tracer for PET scans)
What this could lead to
If successful, this imaging method could help doctors more accurately identify and monitor HER2-positive tumors, potentially guiding treatment decisions.
What could go wrong
This is a very early pilot study with only 30 participants, so results are preliminary. The tracer may not improve detection over current methods, and there is a small risk of side effects from the injection.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 30 people

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

Started

Apr 2026

Expected to finish

Dec 2029

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: 1. Age ≥ 18 years. 2. Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the discretion of their treating physician for an FDA-approved indication. Patients who are planning to start HER2-targeted therapy at the time of study enrollment. Patients who have recently begun HER2 treatment and have received no more than 6 cycles will be eligible for enrollment. 3. Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type. 4. Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver. 5. Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study. Exclusion Criteria: 1. Measurable sites of disease only in the liver. 2. Inability to comply with study procedures. 3. Hypersensitivity or allergy to any component of \[68Ga\]Ga-ABY-025. 4. Pregnant or breastfeeding. 5. HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy. 6. Inability to lie flat for 30 minutes during an imaging session. 7. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.

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Conditions

The condition(s) this trial relates to.

breast neoplasm esophageal squamous cell carcinoma gastric neoplasm head and neck squamous cell carcinoma HER2 positive breast carcinoma metastatic malignant neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

HER 2 low-expressing breast cancer HER2 HER2 + breast cancer, HER2 + gastric cancer, squamous cell carcinoma of head and neck, esophageal squamous cell carcinoma Locally advanced cancer Metastatic cancer

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.