Amgen's AMG 355 Trial Completes First-In-Human Test in Advanced Solid Tumors

Amgen's ongoing clinical study of AMG 355 has reached an important milestone with the completion of its first-in-human trial in advanced solid tumors. The study aimed to test the safety, dose range, and early signs of benefit for AMG 355 alone and in combination with Keytruda, a key combo that could shape future cancer strategies.

The trial tested short intravenous infusions of AMG 355 as a single agent and in combination with pembrolizumab (Keytruda). The goal was to find a practical dose that patients can tolerate while still seeing meaningful biological activity, laying the groundwork for possible phase 2 expansion and broader use in solid tumor settings.

The study design kept things simple and flexible, with non-randomized groups enrolled in sequence. This type of design is typical for first-in-human cancer trials aimed at mapping basic safety and dose limits. The trial was first submitted in November 2023, signaling when formal regulatory tracking began.