AURELIO-04

SOTIO is conducting the Phase 2 (NCT05256381) AURELIO-04 trial studying nanrilkefusp alfa (formerly SOT101) in combination with pembrolizumab. The trial is an open-label, single-arm, multicentered study that is evaluating the efficacy and safety of patients with advanced/refractory solid tumors. The initiation of AURELIO-04 was based on the encouraging data from the Phase 1/1b AURELIO-03 study of nanrilkefusp alfa, which showed early efficacy signals in combination with pembrolizumab, and as single-agent treatment. The Phase 2 trial will enroll up to 320 patients targeting multiple solid tumor indications in Europe and the US. SOTIO entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA) in December 2021. MSD supplies pembrolizumab for the study. Learn more here.