Optimized, automated and cGMP-compliant synthesis of the HER2 targeting [Ga]Ga-ABY-025 tracer.

Background: The Affibody molecule, ABY-025, has demonstrated utility to detect human epidermal growth factor receptor 2 (HER2) in vivo, either radiolabelled with indium-111 (In) or gallium-68 (Ga). Using the latter, Ga, is preferred due to its use in positron emission tomography with superior resolution and quantifying capabilities in the clinical setting compared to In. For an ongoing phase II study (NCT05619016) evaluating ABY-025 for detecting HER2-low lesions and selection of patients for HER2-targeted treatment, the aim was to optimize an automated and cGMP-compliant radiosynthesis of [Ga]Ga-ABY-025.