AMG 404, a New PD-1 Inhibitor, Advances in Early-Phase Trials for Advanced Solid Tumors

In this first-in-human Phase I study of AMG 404, administered every 4 weeks at escalating doses (240, 480, and 1050 mg) across 168 treated patients, the drug demonstrated no dose-limiting toxicities, dose-proportional pharmacokinetics, and promising antitumor activity with an overall objective response rate of 19.6%—notably 36.6% in MSI-H and 30.8% in NSCLC with high PD-L1 expression.

The encouraging safety profile and enhanced efficacy in specific biomarker-defined cohorts underscore AMG 404's potential as a next-generation monotherapy in advanced solid tumors, meriting further Phase II evaluation.