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111In-ABY-002 is a first-generation radiolabeled diagnostic imaging agent developed by Affibody AB for the detection of HER2-positive metastatic breast cancer. It consists of an Affibody molecule (DOTA₀-Z_HER2:342-pep2), which is a small, non-immunoglobulin-based scaffold protein engineered to bind with high affinity to the human epidermal growth factor receptor 2 (HER2). Labeled with the radionuclide Indium-111 (111In) for single-photon emission computed tomography (SPECT) imaging, the tracer allows for the non-invasive assessment of HER2 expression in metastatic lesions. In Phase 1 clinical studies, it demonstrated rapid tumor uptake and the ability to visualize lesions within 2–3 hours of injection, although high liver background limited the detection of liver metastases. It serves as a research precursor to the second-generation agent ABY-025.
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