Therapy Detail

Therapy Name Regorafenib + Cetuximab
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cetuximab Erbitux EGFR Antibody 27 Erbitux (cetuximab) is a monoclonal antibody directed against EGFR, which inhibits signal transduction and cell proliferation (PMID: 28695301). Erbitux (cetuximab) is FDA approved for use in head and neck squamous cell carcinoma and KRAS wild-type, EGFR positive colorectal cancer (FDA.gov).
Regorafenib Stivarga BAY 73-4506 BRAF Inhibitor 18 CRAF Inhibitor 10 KIT Inhibitor 48 PDGFR Inhibitor (Pan) 27 RET Inhibitor 36 VEGFR Inhibitor (Pan) 29 VEGFR2 Inhibitor 34 Stivarga (regorafenib) is an inhibitor of several kinases including VEGFR, RET, KIT, PDGFR and RAF, thereby inhibiting tumor angiogenesis and tumor cell proliferation (PMID: 24756792). Stivarga (regorafenib) is FDA approved for colorectal cancer, hepatocellular carcinoma, and GIST (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KRAS G12V colorectal cancer sensitive Regorafenib + Cetuximab Preclinical Actionable In a preclinical study, the combination of Erbitux (cetuximab) and Stivarga (regorafenib) inhibited growth, reduced Akt and Mapk phosphorylation, and induced apoptosis of human colorectal cancer cell lines harboring KRAS G12V in culture (PMID: 25838391). 25838391
KRAS G13D colorectal cancer sensitive Regorafenib + Cetuximab Preclinical Actionable In a preclinical study, the combination of Erbitux (cetuximab) and Stivarga (regorafenib) inhibited growth, reduced Akt and Mapk phosphorylation, and induced apoptosis in human colorectal cancer cell lines harboring KRAS G13D in culture (PMID: 25838391). 25838391
Unknown unknown Advanced Solid Tumor not applicable Regorafenib + Cetuximab Phase I Actionable In a Phase I trial, the combination of Stivarga (regorafenib) and Erbitux (cetuximab) resulted in a clinical benefit of either stable disease or partial response in 46% (11/24) of advanced solid tumor patients, including eight patients with colorectal cancer, and one patient with head and neck cancer, one with carcinoma of unknown primary, and one with glioblastoma (PMID: 28422758; NCT02095054). 28422758
Clinical Trial Phase Therapies Title Recruitment Status
NCT02095054 Phase I Regorafenib + Cetuximab Regorafenib and Cetuximab in Patients With Advanced Malignancy Active, not recruiting
NCT01973868 Phase I Regorafenib + Cetuximab Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination Completed