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news.Morphotek has begun a multi-center, Phase II study evaluating the safety and efficacy of MORAb-004 in the treatment of metastatic colorectal cancer that is refractory to all standard therapy.
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MORAb-004 is a monoclonal antibody that binds to endosialin/tumor endothelial marker-1 (TEM-1).
The randomized, double-blind study is designed to assess the efficacy and safety of single agent MORAb-004 and best supportive care as determined by progression-free survival in patients with chemorefractory metastatic colorectal cancer.
Secondary objectives of the placebo-controlled study will include assessment of an overall survival benefit, identification of biomarkers to predict efficacy, and safety of single agent MORAb-004.
The trial is expected to enroll up to 160 patients, which is being conducted at clinical centers in the US.
Morphotek clinical development senior director Christina Coughlin said: "The treatment of chemorefractory colorectal cancer remains an area of significant unmet medical need in the field of oncology. We are pleased to have the opportunity to collaborate with several key experts in this disease setting."