Clinical trial
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of…
NCT03600883 · Amgen, Industry · Active, not recruiting
Key facts
| NCT number | NCT03600883 |
|---|---|
| Title | 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) |
| 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… |
| Lead sponsor | Amgen, Industry |
| Status | Active, not recruiting |
| Phase | Phase 1/Phase 2 |
| Study type | Interventional |
| Conditions | KRAS p.G12C Mutant Advanced Solid Tumors |
| Intervention type | Drug |
| Interventions | sotorasib, Anti PD-1/L1, Midazolam |
| Enrollment | 713 |
| Start date | Aug 27, 2018 |
| Primary completion | Feb 28, 2026 |
| Completion | Mar 31, 2026 |
| First posted | Jul 26, 2018 |
| Last update posted | Jan 2, 2026 |
| Countries | Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Hungary, Japan, Portugal, Romania and 4 more |
At a glance
- 100–999 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: