Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy

May 6, 2026 updated by: Eben Rosenthal, Vanderbilt-Ingram Cancer Center
The purpose of this study is to determine if the radiotracer, [68Ga]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will assess a dose of ABY-025 followed by a tracer dose of [68Ga]Ga-ABY-025 in subjects with HER2+ solid cancers, or HER2+ or low breast cancer undergoing or planning to undergo treatment with standard-of-care HER2-targeted therapy for an FDA-approved indication. The study drug will be administered and [68Ga]Ga-ABY-025 PET/CT scan will be obtained the same day after injection of study drug. Patients will have a follow visit 2-7 days post injection of the study drug. Additionally, subjects will undergo standard of care evaluation of their advanced disease per the discretion of their treating physician.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Arm (ABY-025)
This is a pilot study of [68Ga]Ga-ABY-025, a radiolabeled affibody, imaging in patients undergoing treatment with HER2-targeted therapy. The PET/CT imaging ("HER2 PET" imaging) will be performed at, prior to, or during the time a patient is receiving treatment with HER2-targeted therapy. A second HER2 PET will be collected at time of therapy treatment discontinuation or 12 months from study consent. Patients will be infused with the study drug, [68Ga]Ga-ABY-025, followed by PET/CT imaging post infusion. Participants will undergo follow-up visits to assess for adverse reactions 2-7 days post infusion and again at the patient's standard of care visit. Participants will undergo standard of care work-up for their malignancy as determined by their treatment team (e.g. biopsy, additional imaging, observation, treatment for metastatic disease). Either at 12 months after enrollment in the study or at the time of treatment discontinuation (whichever comes first), repeat HER2 PET imaging will
Drug: [68Ga]Ga-ABY-025
Subjects receive a tracer dose of [68Ga]Ga-ABY-025 and will receive a PET/CT scan a few hours after the injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine safety of [68Ga]Ga-ABY-025 PET by assessing for adverse events following the injection and PET imaging.
Time Frame: up to 21± 14 days from second administration of [68Ga]Ga-ABY-025. Assessments will be performed as part of the routine standard of care for patients undergoing HER2-targeted anti-cancer treatment.
Outcome Measure: After study enrollment, subjects will receive [68Ga]Ga-ABY-025 infusion and undergo PET/CT scan. Patients will be immediately assessed for adverse events within the first 30 minutes of infusion and 2-7 days post-infusion from the study coordinator. Adverse events will be monitored up to 21±14 days following the infusion of study drug. Repeat infusion and imaging will be obtained either at the time of treatment discontinuation or at 12 months from study consent and will have the same safety monitoring parameters. While there are expected adverse events related to anti-cancer therapy, we will specifically be reporting adverse events that are "definitely related" or "probably related" to the study agent.
up to 21± 14 days from second administration of [68Ga]Ga-ABY-025. Assessments will be performed as part of the routine standard of care for patients undergoing HER2-targeted anti-cancer treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICCBREP24601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is unknown if and/or how we will plan IPD with outside researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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