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)
Public ClinicalTrials.gov record NCT03600883. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03600883
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 713 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 27, 2018 (Actual)
- Primary completion
- May 29, 2026 (Actual)
- Completion
- May 29, 2026 (Actual)
- Last update posted
- Jun 30, 2026
2018 – 2026
United States locations
- U.S. sites
- 39
- U.S. states
- 21
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| University of California at SF | San Francisco | California | 94115 | — |
| Sarcoma Oncology Research Center LLC | Santa Monica | California | 90403 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | — |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06510 | — |
| Medical Oncology Hematology Consultants Helen F Graham Cancer Center | Newark | Delaware | 19713 | — |
| University of Florida Health | Gainesville | Florida | 32610 | — |
| AdventHealth Orlando Infusion Center | Orlando | Florida | 32804 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | 20817 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Washington University | St Louis | Missouri | 63110-1093 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Laura and Isaac Perlmutter Cancer Center at New York University Langone | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Duke University Medical Center, Morris Cancer Clinic | Durham | North Carolina | 27710 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburgh Medical Center Cancer Pavillion | Pittsburgh | Pennsylvania | 15232 | — |
| Gibbs Cancer Center and Research Institute - Spartanburg | Spartanburg | South Carolina | 29303 | — |
| Vanderbilt University Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Texas Oncology - Austin Central | Austin | Texas | 78731 | — |
| Texas Oncology - Baylor | Dallas | Texas | 75246 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| US Oncology Research Investigational Products Center | Fairfax | Virginia | 22031 | — |
| Virginia Cancer Specialists PC | Fairfax | Virginia | 22031 | — |
| Blue Ridge Cancer Care | Salem | Virginia | 24153 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 94 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03600883, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03600883 live on ClinicalTrials.gov.