Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Public ClinicalTrials.gov record NCT04185883. 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 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Study identification
- NCT ID
- NCT04185883
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 610 participants
Conditions and interventions
Interventions
- 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 Drug
Drug
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
- Dec 17, 2019 (Actual)
- Primary completion
- Dec 17, 2026 (Estimated)
- Completion
- Dec 5, 2027 (Estimated)
- Last update posted
- Oct 22, 2025
2019 – 2027
United States locations
- U.S. sites
- 55
- U.S. states
- 24
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates Professional Corporation | Tucson | Arizona | 85711 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Loma Linda University Cancer Center | Loma Linda | California | 92354 | — |
| University of Southern California, Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| University of California San Francisco Mission Bay Campus | San Francisco | California | 94115 | — |
| University of California Los Angeles | Santa Monica | California | 90404 | — |
| Rocky Mountain Cancer Centers Denver Midtown | Denver | Colorado | 80218 | — |
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | — |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | — |
| Memorial Cancer Institute | Pembroke Pines | Florida | 33028 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Johns Hopkins University | Baltimore | Maryland | 21224 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-5912 | — |
| Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion) | Detroit | Michigan | 48202 | — |
| Washington University | St Louis | Missouri | 63110-1093 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 32224 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| Gibbs Cancer Center and Research Institute - Spartanburg | Spartanburg | South Carolina | 29303 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57108 | — |
| United States Oncology Regulatory Affairs Corporate Office | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Oncology Central-South | Austin | Texas | 78705 | — |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Oncology Consultants | Houston | Texas | 77030 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| US Oncology Research Investigational Products Center | The Woodlands | Texas | 77380 | — |
| Texas Oncology Northeast Texas | Tyler | Texas | 75702 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22903 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | — |
| Northwest Cancer Specialists - Vancouver | Vancouver | Washington | 98684 | — |
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 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04185883, 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 Oct 22, 2025 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04185883 live on ClinicalTrials.gov.