The Phase I dose-escalation trial will enrol up to 18 patients with bavituximab in combination with the chemotherapeutic agent capecitabine and radiation therapy.
The study principal investigator, the University of Texas Southwestern Medical Center radiation oncology assistant professor Jeffrey Meyer said preclinical studies have repeatedly shown that radiation increases the exposure of bavituximab’s target molecule, PS, on the surface of tumour blood vessel cells.
"Additionally, bavituximab in combination with radiation therapy has demonstrated potent anti-tumor effects in models of lung and brain cancer, with evidence of enhanced immunity," Meyer added.
The primary endpoint of the single-arm, open-label study is to evaluate the safety, feasibility and tolerability of the combination of bavituximab with a standard platform of capecitabine and radiation therapy.
Secondary endpoints include the assessment of any anti-tumour activity by objective response as determined by MR imaging and histopathological response in patients.
Bavituximab is a phosphatidylserine-targeting antibody that has demonstrated promising tumour response and survival trends in randomized Phase II trials in non-small cell lung cancer.