An Exploratory Study to Evaluate [68Ga]ABY-025 for PET Imaging of HER2 Expression in Subjects With Metastatic Breast Cancer
Open-labeled, exploratory, single center study.
1. Group 1 (dose-finding) Six subjects with HER2-positive primary tumor status and four
subjects with HER2-negative status. [68Ga]ABY-025 PET with low dose (100 μg) of
ABY-025 peptide is performed, followed by a repeated PET within three weeks using high
dose (500 μg) ABY-025 peptide (radioactivity maximum 500 MBq). A third [68Ga]ABY-025
PET will be performed in the HER2-positive subgroup only, when signs of progressive
disease are found at routine clinical evaluation or else latest after 12 months
regardless of disease status, then using the ABY-025 peptide dose previously determined
to be preferable.
2. Group 2 Ten subjects with HER2-positive primary tumor status. [68Ga]ABY-025 PET is
performed using the ABY-025 peptide dose determined to be preferable during the
dose-finding part of the study, followed by a second [68Ga]ABY-025 PET investigation at
signs of progressive disease or else latest after 9 months.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
PET image analysis: Standardized Uptake Value (SUV) and uptake kinetics of [68Ga]ABY-025 in breast cancer lesions and normal tissues
Henrik Lindman, MD, PhD
Uppsala University Hospital, Department of Oncology
Sweden: Medical Products Agency