Clinical Trial

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

Completed Phase 1/2
View on ClinicalTrials.gov →
Summary
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Protocol Amendment History 1 change
critical Trial completed 2026-07-01
Trial Details
NCT Number NCT03600883
Lead Sponsor Amgen
Conditions KRAS p.G12C Mutant Advanced Solid Tumors
Enrollment 713 participants
Start Date 2018-08-27
Primary Completion 2026-05-29 (estimated)
Study Completion 2026-05-29 (estimated)
Updated on ClinicalTrials.gov 2026-06-30