Pancreatic Cancer Research

Clinical trialPhase 1 / Phase 2Completed

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)

NCT03600883↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Finished, no results posted
Phase
Phase 1 / Phase 2
Status
Completed
Study type
Interventional
Start
27 August 2018
Expected end
29 May 2026
Enrollment
713 participants
Sites
133
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
Sponsor
Industry
Results posted
No
Last update
30 June 2026

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Brief summary public domain (ClinicalTrials.gov)

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.

Papers 3