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Therapy Name | Cetuximab + Regorafenib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Cetuximab | Erbitux | IMC-C225 | EGFR Antibody 31 | 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 20 CRAF Inhibitor 12 KIT Inhibitor 51 PDGFR Inhibitor (Pan) 27 RET Inhibitor 39 VEGFR Inhibitor (Pan) 32 VEGFR2 Inhibitor 35 | 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 |
---|---|---|---|---|---|---|---|
BRAF V600E PIK3CA P449T | colorectal cancer | sensitive | Cetuximab + Regorafenib | 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 BRAF V600E and PIK3CA P449T in culture (PMID: 25838391). | 25838391 |
Unknown unknown | Advanced Solid Tumor | not applicable | Cetuximab + Regorafenib | 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 | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT02095054 | Phase I | Cetuximab + Regorafenib | Regorafenib and Cetuximab in Patients With Advanced Malignancy | Completed | USA | 0 |
NCT01973868 | Phase I | Cetuximab + Regorafenib | Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination | Completed | USA | 0 |