Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy (NCT06828588) | Clinical Trial Compass
RecruitingEarly Phase 1
Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
United States30 participantsStarted 2026-04-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Determine safety of [68Ga]Ga-ABY-025 PET by assessing for adverse events following the injection and PET imaging.
Timeframe: 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.
. 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.