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Clinical Trials in the UK / NCT04185883
Active, not recruiting Phase 1

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

NCT04185883 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 1
Started
2019-12-17
Last updated
2025-10-22

Condition(s) studied

Advanced Solid TumorsKirsten Rat Sarcoma (KRAS) pG12C Mutation

Investigational drug(s) / intervention(s)

Sotorasib →Trametinib →RMC-4630Afatinib →Pembrolizumab →Panitumumab →Carboplatin, pemetrexed, docetaxel, paclitaxelAtezolizumab →Palbociclib →MVASI® (bevacizumab-awwb) →TNO155 →IV Chemotherapy (Regimen 1)IV Chemotherapy (Regimen 2)BI 1701963 →AMG 404Everolimus →

Sotorasib: Sotorasib administered orally as a tablet.

Trametinib: Trametinib administered orally as a tablet.

RMC-4630: RMC-4630 administered orally as a capsule.

Afatinib: afatinib administered orally as a tablet.

Pembrolizumab: pembrolizumab administered as an intravenous (IV) infusion.

Panitumumab: Panitumumab administered as an IV infusion.

Carboplatin, pemetrexed, docetaxel, paclitaxel: Carboplatin, pemetrexed, docetaxel administered as an IV infusion.

Atezolizumab: Atezolizumab administered as an IV injection.

Palbociclib: Palbociclib administered orally as a tablet.

MVASI® (bevacizumab-awwb): MVASI® (bevacizumab-awwb) administered as an IV infusion.

TNO155: TNO155 administered orally as a capsule.

IV Chemotherapy (Regimen 1): Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.

IV Chemotherapy (Regimen 2): IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.

BI 1701963: BI 1701963 administered orally

AMG 404: AMG 404 administered as an IV infusion.

Everolimus: Everolimus administered orally.

Study summary

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * Men or women greater than or equal to 18 years old. * Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Exclusion Criteria: * Primary brain tumor. * Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors. * Myocardial infarction within 6 months of study day 1. * Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Primary outcome measure(s)

  • Number of Participants with Dose Limiting Toxicities (DLTs) — 12 Months
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) — 12 Months
  • Number of Participants with Treatment-related Adverse Events — 12 Months
  • Number of Participants with Clinically Significant Changes in Vital Signs — 12 Months
  • Number of Participants with Clinically Significant Changes in ECG Measurements — 12 Months
  • Number of Participants with Clinically Significant Changes in Laboratory Test Values — 12 Months

Trial sites (90)

FacilityCityRegionStatus
Arizona Oncology Associates Professional Corporation Tucson Arizona
City of Hope National Medical Center Duarte California
University of California San Diego Moores Cancer Center La Jolla California
Loma Linda University Cancer Center Loma Linda California
University of Southern California, Norris Comprehensive Cancer Center Los Angeles California
University of California Davis Medical Center Sacramento California
University of California San Francisco Mission Bay Campus San Francisco California
University of California Los Angeles Santa Monica California
Rocky Mountain Cancer Centers Denver Midtown Denver Colorado
Sarah Cannon Research Institute Denver Colorado
Yale New Haven Hospital New Haven Connecticut
Norwalk Hospital Norwalk Connecticut
Memorial Cancer Institute Pembroke Pines Florida
Moffitt Cancer Center Tampa Florida
Emory University Atlanta Georgia
Northwestern University Chicago Illinois
University of Chicago Chicago Illinois
Indiana University Indianapolis Indiana
University of Iowa Hospitals and Clinics Iowa City Iowa
Johns Hopkins University Baltimore Maryland
University of Michigan Ann Arbor Michigan
Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion) Detroit Michigan
Washington University St Louis Missouri
Roswell Park Cancer Institute Buffalo New York
Icahn School of Medicine at Mount Sinai New York New York
Columbia University Irving Medical Center New York New York
Memorial Sloan Kettering Cancer Center New York New York
Montefiore Medical Center The Bronx New York
Levine Cancer Institute Charlotte North Carolina
Duke University Durham North Carolina
University of Cincinnati Medical Center Cincinnati Ohio
Cleveland Clinic Foundation Cleveland Ohio
Providence Portland Medical Center Portland Oregon
Oregon Health and Science University Portland Oregon
Thomas Jefferson University Philadelphia Pennsylvania
Fox Chase Cancer Center Philadelphia Pennsylvania
University of Pennsylvania Philadelphia Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Gibbs Cancer Center and Research Institute - Spartanburg Spartanburg South Carolina
Avera Cancer Institute Sioux Falls South Dakota

+ 50 more sites — see the full list on the official registry below.

On this site

📄 Lumakras (sotorasib) drug profile → 📄 Keytruda (pembrolizumab) drug profile → 📄 Tecentriq (atezolizumab) drug profile → 📄 Ibrance (palbociclib) drug profile →

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Other trials for the same condition

A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors Recruiting
A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors Active, not recruiting
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Active, not recruiting
A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors Active, not recruiting
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04185883 on ClinicalTrials.gov ↗ ← All trials in the UK