Enrollment opens for ImClone's Ph II IMC-1121B study

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

This Phase II single-arm, multicenter trial 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. A total of 36 patients are expected to be included. The study is designed to evaluate the efficacy, safety and pharmacology of IMC-1121B administered every two weeks by intravenous infusion.

"We are excited to have begun the Phase II study of IMC-1121B for advanced kidney cancer, as Phase I studies have shown this antibody's ability to induce notable tumor responses as a single agent in various refractory tumor types, as well as having a favorable safety profile, all of which was predicted from our preclinical studies," said Eric Rowinsky, chief medical officer. "This disease-directed study of IMC-1121B represents the first of a wide range of activity-finding studies, many of which will begin over the next several months in various rational tumor types," he added.