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

Early Phase 1

Not yet recruiting

• Conditions: Locally Advanced Cancer; Metastatic Cancer
• Interventions: Drug: ABY-025 Loading Dose; Drug: [68Ga]Ga-ABY-025

• Registration Number: NCT06828588
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-02-10
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Study Start: 2025-05
• Primary Completion: 2027-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 may be actively undergoing or planning to start HER2-targeted therapy at the time of study enrollment.
3. Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ patients 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 on 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm (ABY-025)	ABY-025 Loading Dose	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 3 hours +/- 30minutes 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
Study Arm (ABY-025)	[68Ga]Ga-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, Ga-ABY-025, on Day 0, followed by PET/CT imaging 3 hours +/- 30minutes 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

Primary Outcome Measures

Name	Time	Method
Determine safety of [68Ga]Ga-ABY-025 PET. We will assess the number of adverse events (AEs) that are possibly or probably related to the study drug within 24 hours after infusion. Dose limiting toxicities will be defined as an AE grade >2 that is clini	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 via phone call at 2 days (+/- 1 day) 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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States