ClinicalTrials.gov record
Active, not recruiting Phase 1 Interventional

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

ClinicalTrials.gov ID: NCT04185883

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.

ClinicalTrials.gov public records Last synced May 10, 2026, 1:29 AM EDT

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)

Study identification

NCT ID
NCT04185883
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Amgen
Industry
Enrollment
610 participants

Conditions and interventions

Interventions

  • AMG 404 Drug
  • Afatinib Drug
  • Atezolizumab Drug
  • BI 1701963 Drug
  • Carboplatin, pemetrexed, docetaxel, paclitaxel Drug
  • Everolimus Drug
  • IV Chemotherapy (Regimen 1) Drug
  • IV Chemotherapy (Regimen 2) Drug
  • MVASI® (bevacizumab-awwb) Drug
  • Palbociclib Drug
  • Panitumumab Drug
  • Pembrolizumab Drug
  • RMC-4630 Drug
  • Sotorasib Drug
  • TNO155 Drug
  • Trametinib 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 16, 2019
Primary completion
Dec 16, 2026
Completion
Dec 4, 2027
Last update posted
Oct 21, 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 21, 2025 · Synced May 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04185883 live on ClinicalTrials.gov.

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