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)
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Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
713actual
Sites
133
Countries
Australia, Austria, Belgium +13
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2018-08-27 | actual | When the study began enrolling |
| Primary completion | 2026-05-29 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-05-29 | actual | The whole study's end, after follow-up |
| First posted | 2018-07-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- KRAS p.G12C Mutant Advanced Solid Tumors
Interventions
- Drug: sotorasib
- Drug: Anti PD-1/L1
- Drug: Midazolam
Primary outcomes
what the primary-completion date above is the date OFPrimary: Number of subjects with treatment-emergent adverse events
measured 24 Months
Primary: Number of subjects with treatment-related adverse events
measured 24 Months
Primary: Number of subjects with grade ≥3 treatment-emergent adverse events
measured 24 Months
Primary: Number of subjects with serious adverse events
measured 24 Months
Primary: Number of subjects with adverse events of interest
measured 24 Months
Primary: Number of subjects with clinically significant changes in vital signs
measured Baseline to 24 Months
Primary: Number of subjects with clinically significant changes in physical examination results
measured Baseline to 24 Months
Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs)
measured Baseline to 24 Months
Primary: Number of subjects with clinically significant changes in clinical laboratory values
measured Baseline to 24 Months
Primary: Number of subjects with dose-limiting toxicities (DLTs)
measured 21 Days
Primary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria
measured 24 Months
Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria
measured 24 Months
Primary: Disease control as assessed by RECIST 1.1 criteria
measured 24 Months
Primary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria
measured 24 Months
Primary: Time to response (TTR) as assessed by RECIST 1.1 criteria
measured 24 Months
Publications
- PMID 31666701 — cited as background
- PMID 34096690 — cited as background
- PMID 34919824 — cited as background
- PMID 32955176 — cited as background
- PMID 34759319 — cited as background
- PMID 37098232 — cited as background
- PMID 38010044 — cited as background
- PMID 38975874 — cited as background
- PMID 39029295 — cited as background
- PMID 39806205 — cited as background
- PMID 36546651 — linked by the registry
- PMID 31820981 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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