Clinical Trials in Germany / 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 Germany 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

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)

Facility	City	Region
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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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 Germany