To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
610
Sotorasib administered orally as a tablet.
Trametinib administered orally as a tablet.
RMC-4630 administered orally as a capsule.
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: 12 Months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: 12 Months
Number of Participants with Treatment-related Adverse Events
Time frame: 12 Months
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: 12 Months
Number of Participants with Clinically Significant Changes in ECG Measurements
Time frame: 12 Months
Number of Participants with Clinically Significant Changes in Laboratory Test Values
Time frame: 12 Months
Maximum Plasma Concentration (Cmax)
Time frame: 12 Months
Time to Maximum Plasma Concentration (Tmax)
Time frame: 12 Months
Area Under the Plasma Concentration-time Curve (AUC)
Time frame: 12 Months
Objective Response Rate
Time frame: 12 Months
Disease Control Rate
Time frame: 12 Months
Duration of Response
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
afatinib administered orally as a tablet.
pembrolizumab administered as an intravenous (IV) infusion.
Panitumumab administered as an IV infusion.
Carboplatin, pemetrexed, docetaxel administered as an IV infusion.
Atezolizumab administered as an IV injection.
Palbociclib administered orally as a tablet.
MVASI® (bevacizumab-awwb) administered as an IV infusion.
TNO155 administered orally as a capsule.
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 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 administered orally
AMG 404 administered as an IV infusion.
Everolimus administered orally.
Arizona Oncology Associates Professional Corporation
Tucson, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
University of California San Diego Moores Cancer Center
La Jolla, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California San Francisco Mission Bay Campus
San Francisco, California, United States
University of California Los Angeles
Santa Monica, California, United States
Rocky Mountain Cancer Centers Denver Midtown
Denver, Colorado, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
...and 80 more locations
Time frame: 12 Months
Progression-free Survival
Time frame: 12 Months
Duration of Stable Disease
Time frame: 12 Months
Time to Response
Time frame: 12 Months
Overall Survival
Time frame: 12 Months
Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels
Time frame: 12 Months
Sotorasib Monotherapy Only: Intracranial Objective Response Rate
Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Time frame: 12 Months
Sotorasib Monotherapy Only: Intracranial Disease Control Rate
Intracranial disease control rate assessed per RANO-BM.
Time frame: 12 Months
Sotorasib Monotherapy Only: Intracranial Duration of Response
Intracranial duration of response assessed per RANO-BM.
Time frame: 12 Months
Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy
Time frame: 12 Months
Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS)
Intracranial PFS assessed per RANO-BM.
Time frame: 12 Months
Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS)
Non-intracranial PFS assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: 12 Months
Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS)
Overall PFS assessed per RECIST 1.1 and RANO-BM.
Time frame: 12 Months
Sotorasib + TNO155 Only: Best Overall Response
Time frame: 12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: 12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: 12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events
Time frame: 12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: 12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements
Time frame: 12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values
Time frame: 12 Months