Phase I study of AUBE00, an oral KRAS-targeting agent in solid tumors

This first-in-human Phase I study evaluates safety, pharmacokinetics, pharmacodynamics, immunogenicity, and anti-tumor activity of AUBE00 in patients with locally advanced or metastatic solid tumors harboring KRAS alterations. The open-label, multicenter trial includes dose escalation and expansion phases with oral administration to determine safe dosing parameters and maximum tolerated dose. Sponsored by Chugai Pharmaceutical, the study aims to provide early insights into this novel mechanism for patients with refractory solid tumors; beyond KRAS G12C inhibitors (sotorasib/adagrasib), direct KRAS options are scarce—broader KRAS activity would be practice-shifting.