First-in-human phase I study of hypoxia-targeting 64 Cu-ATSM radioligand therapy in patients with malignant brain tumors (STAR-64).

Eighteen patients received 64 Cu-ATSM: grade 3 glioma (anaplastic astrocytoma and anaplastic oligodendroglioma) 27.8%, grade 4 glioma (glioblastoma) 50%, malignant meningioma 11.1%, and metastatic brain tumors 11.1%.

Dose-limiting toxicities, consisting only of grade 3 lymphopenia, were observed in four patients: one at 60 MBq/kg, one at 99 MBq/kg, and two at 150 MBq/kg.