Advanced Accelerator Applications Announces First Patient in Bridging Study in Japan for Lutetium Lu 177 Dotatate (Lutathera®)


AAA today announced that the first patient has been treated in a Phase I clinical study of lutetium Lu 177 dotatate* in patients with inoperable, somatostatin receptor positive, progressive pancreatic, gastrointestinal, or pulmonary neuroendocrine tumors (NETs) in Japan. The primary objective of this open-label, uncontrolled, single-center, bridging study is to evaluate the safety, tolerability, pharmacokinetics, and dosimetry of lutetium Lu 177 dotatate in Japanese patients. Six subjects will be included in the Phase I study.