(ChemotherapyAdvisor) – Phase 2 clinical trials are about to begin for MORAb-004, a candidate therapy for metastatic colorectal cancer, according to an announcement today from Morphotek, Inc., Exton, PA. MORAb-004, a monoclonal antibody that specifically binds to endosialin/tumor endothelial marker-1 (TEM-1), will enter a randomized, double-blind, placebo-controlled, multicenter study to evaluate its safety and efficacy in the treatment of metastatic colorectal cancer that is refractory to all standard therapy.
The primary objective of the trial is to determine progression-free survival in patients with chemorefractory metastatic colorectal cancer. Secondary objectives include assessment of an overall survival benefit, identification of biomarkers to predict efficacy, and safety of single agent MORAb-004, according to the company.
The trial, which will be conducted at clinical sites in the United States, is expected to enroll up to 160 patients. The goal of these investigations is to identify those patients who had a clinically meaningful response to MORAb-004.
“We are excited to have initiated this Phase 2 study of MORAb-004 in metastatic colorectal cancer,” stated Christina Coughlin, MD, PhD, Senior Director of Clinical Development at Morphotek. “New agents are needed for the treatment of metastatic colorectal cancer. 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.”