Study of IMC-1121B for Advanced Renal Cell Cancer Opens for Patient Enrollment

ImClone Systems announced that the first of its disease-directed clinical trials of the anti-vascular endothelial growth factor receptor-2 (VEGFR-2) monoclonal antibody IMC-1121B has opened for patient enrollment.

The Phase II single-arm, multicenter study of IMC-1121B is enrolling patients with metastatic renal cell carcinoma whose disease has progressed during therapy with an approved VEGFR-2 tyrosine kinase inhibitor or who have developed intolerance to these agents. ImClone said it expects a total of 36 patients to be enrolled.

The study is designed to evaluate the efficacy, safety and pharmacology of IMC-1121B administered every two weeks by intravenous infusion, the company said. IMC-1121B is a fully human IgG1 monoclonal antibody that is designed to bind to the VEGFR-2 found on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from binding to and activating the receptor.

This action blocks a signaling pathway key to new blood vessel formation in growing tumors, which has been shown to starve tumors of their nutrient supply and result in significant tumor growth inhibition in preclinical models, according to ImClone.