NCT03600883

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Official title

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)

Phase

Phase 1/Phase 2

Status

Completed

Conditions

KRAS p.G12C Mutant Advanced Solid Tumors

Interventions

sotorasib; Anti PD-1/L1; Midazolam

Arms

• Phase 1 Dose Exploration Part 1 monotherapy · Experimental
• Phase 1 Dose Expansion Part 2 monotherapy · Experimental
• Phase 1 combination arm with sotorasib and anti PD-1/L1 · Experimental
• Phase 1 monotherapy treatment naive advanced NSCLC · Experimental
• Phase 2 monotherapy dose comparison · Experimental
• Phase 1 Does escalation and Expansion monotherapy BID · Experimental

Enrollment

713

Primary outcomes

• Primary: Number of subjects with treatment-emergent adverse events
• Primary: Number of subjects with treatment-related adverse events
• Primary: Number of subjects with grade ≥3 treatment-emergent adverse events
• Primary: Number of subjects with serious adverse events
• Primary: Number of subjects with adverse events of interest
• Primary: Number of subjects with clinically significant changes in vital signs
• Primary: Number of subjects with clinically significant changes in physical examination results
• Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs)
• Primary: Number of subjects with clinically significant changes in clinical laboratory values
• Primary: Number of subjects with dose-limiting toxicities (DLTs)
• Primary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria
• Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria
• Primary: Disease control as assessed by RECIST 1.1 criteria
• Primary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria
• Primary: Time to response (TTR) as assessed by RECIST 1.1 criteria

Sponsor

Amgen

Start

Aug 27, 2018

Primary completion

May 29, 2026

Results posted

No

Registry record

NCT03600883 · updated Jun 30, 2026

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