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news.Medarex has reported the allowance of an investigational new drug application filed with the FDA for MDX-1411 for the treatment of CD70-expressing malignancies, with the initial clinical study to focus on the treatment of clear cell renal cell carcinoma.
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The open-label, multi-center, dose-escalation, multi-dose Phase I clinical trial is expected to enroll up to 40 patients with advanced clear cell renal cell carcinoma (ccRCC) and is designed to determine the safety, tolerability and maximum tolerated dose of MDX-1411 as well as characterize preliminary efficacy and pharmacokinetics.
MDX-1411 is a fully human monoclonal antibody that targets the CD70 receptor, which is a member of the tumor necrosis factor (TNF) family. MDX-1411 was generated by Medarex’s UltiMAb Human Antibody Development System.
Howard Pien, president and CEO of Medarex, said: “The advancement of this antibody into the clinical trial process adds to our internal pipeline and expands our portfolio of potentially new oncology therapeutics.”