The randomised, double-blind, placebo-controlled study will evaluate MORAb-004, a monoclonal antibody that specifically binds to endosialin/tumor endothelial marker-1 (TEM-1).
Using an adaptive design, the trial will enrol up to 200 patients and test their tumors and plasma samples for endosialin/TEM-1 and/or proteins within its pathway to determine if the pattern of expression relates to or determines clinical effect.
Morphotek clinical development senior director Christina Coughlin said company has initiated the Phase II study of MORAb-004 in metastatic soft tissue sarcoma, combining MORAb-004 with a standard chemotherapy regimen.
"New agents are needed for the treatment of metastatic soft tissue sarcoma, an orphan disease that remains an area of significant unmet medical need," Coughlin added.
The progression-free survival is the primary endpoint of the trial while the 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.