RecruitingEarly Phase 1NCT06828588
Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
Sponsor
Vanderbilt-Ingram Cancer Center
Enrollment
30 participants
Start Date
Apr 16, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Age ≥ 18 years.
- 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.
- 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.
- Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.
- Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study.
Exclusion Criteria7
- Measurable sites of disease only in the liver.
- Inability to comply with study procedures.
- Hypersensitivity or allergy to any component of \[68Ga\]Ga-ABY-025.
- Pregnant or breastfeeding.
- HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.
- Inability to lie flat for 30 minutes during an imaging session.
- 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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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06828588
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