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

Vanderbilt University Medical Center

Status and phase: Not yet enrolling; Early Phase 1

Conditions: HER 2 Low-expressing Breast Cancer; Metastatic Cancer; Locally Advanced Cancer; HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma; HER2

Treatments: Drug: [68Ga]Ga-ABY-025; Drug: ABY-025 Loading Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT06828588

VICCBREP24601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Study Arm (ABY-025)

Experimental group

Description:

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, Ga-ABY-025, on Day 0, followed by PET/CT imaging post infusion. Participants will undergo follow-up visits to assess for adverse reactions at 24 hours and 21 days post infusion (± 7 days). 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

Treatment:

Drug: ABY-025 Loading Dose

Drug: [68Ga]Ga-ABY-025