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

NCT06828588•Vanderbilt-Ingram Cancer Center

Summary

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.

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 on Day 0, and \[68Ga\]Ga-ABY-025 PET/CT scan will be obtained the same day after injection of study drug. Patients will receive a phone call from a study coordinator post-injection to assess for adverse events. Subjects will undergo standard of care evaluation of their advanced disease per the discretion of their treating physician.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Key Dates

Start Date

February 1, 2026

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2029

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

Locally Advanced CancerMetastatic CancerHER2HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell CarcinomaHER 2 Low-expressing Breast Cancer

Interventions

ABY-025 Loading Dose

DRUG

[68Ga]Ga-ABY-025

DRUG

Contacts

Nicole Jones

CONTACT

615-936-2807 nicole.l.jones@vumc.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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