Peregrine Pharmaceuticals, a clinical-stage biopharmaceutical company, has started an investigator-sponsored trial (IST) for patients with stage II or stage III rectal adenocarcinoma.
The Phase I single-arm, open-label, dose-escalation trial will enrol up to 18 patients with bavituximab, the company's investigational monoclonal antibody, 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 that preclinical studies have repeatedly shown that radiation increases the exposure of bavituximab's target molecule, PS, on the surface of tumour blood vessel cells.
"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 said.
"We look forward to evaluating this promising treatment combination in patients with advanced rectal cancer."
The primary endpoint of the 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, which has demonstrated promising tumour response and survival trends in randomised Phase II trials in non-small cell lung cancer.
Joseph Shan, Peregrine clinical and regulatory affairs vice president, said that building on consistently promising data in multiple preclinical tumour models, the trial would represent the first clinical study of bavituximab combined with radiation.
"We intend for this trial to be the first step in assessing bavituximab's potential benefit in several additional oncology indications commonly treated with radiation therapy," he said.