Clinical Trial 21022

Study Title

A Phase 1b/2, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN sotorasib) in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

Summary

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Objective

1. To evaluate the safety and tolerability of AMG 510 administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumors; 2. To characterize PK of product(s) used in investigational regimens of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors; 3. To evaluate anti-tumor activity of investigational regimens of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors.