Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
← catalyst calendarNCT04185883 · readout in 120 d
Sponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
610actual
Sites
90
Countries
Australia, Austria, Belgium +10
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 | 2019-12-17 | actual | When the study began enrolling |
| Primary completion | 2026-12-17 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-05 | estimated | The whole study's end, after follow-up |
| First posted | 2019-12-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Solid Tumors
- Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Interventions
- Drug: Sotorasib
- Drug: Trametinib
- Drug: RMC-4630
- Drug: Afatinib
- Drug: Pembrolizumab
- Drug: Panitumumab
- Drug: Carboplatin, pemetrexed, docetaxel, paclitaxel
- Drug: Atezolizumab
- Drug: Palbociclib
- Drug: MVASI® (bevacizumab-awwb)
- Drug: TNO155
- Drug: IV Chemotherapy (Regimen 1)
- Drug: IV Chemotherapy (Regimen 2)
- Drug: BI 1701963
- Drug: AMG 404
- Drug: Everolimus
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Dose Limiting Toxicities (DLTs)
measured 12 Months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
measured 12 Months
Number of Participants with Treatment-related Adverse Events
measured 12 Months
Number of Participants with Clinically Significant Changes in Vital Signs
measured 12 Months
Number of Participants with Clinically Significant Changes in ECG Measurements
measured 12 Months
Number of Participants with Clinically Significant Changes in Laboratory Test Values
measured 12 Months
Publications
- PMID 38177853 — cited as background
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.
Permalink · AMGN's whole pipeline · Catalyst calendar · Every registered study · What changed