NCT03600883

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)

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 713 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• KRAS p.G12C Mutant Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	sotorasib	Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral Tablet formulation
DRUG	Anti PD-1/L1	Administered as an intravenous (IV) infusion
DRUG	Midazolam	Administered as an oral hydrochloride (HCI) syrup

Timeline

• Start date: 2018-08-27
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2018-07-26
• Last updated: 2026-03-16

Locations

133 sites across 16 countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Hungary, Japan, Portugal, Romania, South Korea, Spain, Switzerland

Regulatory

• FDA-regulated drug study