Morphotek®, Inc. announced today that it has commenced a multi-center, Phase II study evaluating the safety and efficacy of MORAb-004 when combined with gemcitabine and docetaxel in the treatment of metastatic soft tissue sarcoma. MORAb-004 is a monoclonal antibody that specifically binds to endosialin/tumor endothelial marker-1 (TEM-1).
MORAb-004 is thought to function as an inhibitor of the tumor microenvironment. TEM-1 is thought to play a key role in the organization of the tumor cells and support systems (i.e. stroma cells and blood vessels) in most cancer types. Combining a TEM-1 inhibitor such as MORAb-004 with tumor cell targeting agents such as chemotherapy may attack two key parts of the tumor: the tumor cells directly and its supporting structure.
The trial is a randomized, double-blind, placebo-controlled study with a primary endpoint of progression-free survival. Secondary objectives include assessment of an overall survival benefit, identification of biomarkers to predict efficacy, and safety of MORAb-004 in combination with gemcitabine and docetaxel. The trial will use an adaptive design to most efficiently enroll the various subsets of sarcoma.