Morphotek, a subsidiary of Eisai, has begun a Phase II study evaluating MORAb-004 in metastatic soft tissue sarcoma patients, by combining MORAb-004 with a standard chemotherapy regimen.
The randomised, double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of MORAb-004, a monoclonal antibody that specifically binds to endosialin/tumour endothelial marker-1 (TEM-1), when combined with gemcitabine and docetaxel in the treatment of metastatic soft tissue sarcoma.
Combining a TEM-1 inhibitor with chemotherapy may enable tumour cells and their supporting structure to be attacked directly, as TEM-1 is believed to play a vital role in the organisation of the tumour cells in most cancer types.
Morphotek clinical development senior director Dr Christina Coughlin said the company is keen to have initiated the Phase II study due to the need for treatments in this sector.
"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 said.
The trial is expected to use an adaptive design to enrol up to 200 patients.
Tumours and plasma samples will be tested for endosialin/TEM-1 and/or proteins within its pathway to determine if the pattern of expression relates to or determines clinical effect.
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.