US-based Tracon Pharmaceuticals has started dosing in the Phase II portion of a clinical trial assessing its anti-endoglin antibody TRC105 in combination with Votrient (pazopanib), a vascular endothelial growth factor (VEGF) inhibitor, to treat patients with soft tissue sarcoma.
Currently, TRC105 is being evaluated in several clinical trials in combination with agents that inhibit angiogenesis by targeting the VEGF pathway.
Tracon president and CEO Charles Theuer said: "Soft tissue sarcoma is an angiogenesis-driven tumour with limited treatment options available for patients.
"Based on our experience in the Phase I portion of the clinical trial, where the combination of TRC105 and Votrient was well-tolerated, we are moving forward into the Phase II portion of the clinical trial and look forward to working closely with our investigators and collaborators."
The company has completed dose escalation in the Phase I portion of the trial, which showed that the combination was well-tolerated at the approved dose of Votrient and the recommended Phase II dose of TRC105.
The Phase II portion of the trial is a multicentre, open-label, nonrandomised clinical study of TRC105 in combination with Votrient in patients with soft tissue sarcoma.
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Around 60 patients are expected to be enrolled at eight sites in the US, including the sites that conducted the Phase I portion of the clinical trial.
The clinical sites include Mayo Clinic-Rochester, Mayo Clinic-Jacksonville, Duke University, Mount Sinai Hospital, Sarcoma Oncology Center-Santa Monica, and the University of Alabama-Birmingham.
The company expects to correlate progression-free survival and overall response rate with endoglin expression on sarcoma tissue in the Phase II portion of the trial, in order to evaluate whether direct endoglin expression on sarcoma cells may serve as a biomarker that identifies responsive sarcoma subtypes.
Image: Labelled CT image of undifferentiated soft tissue sarcoma in left lung of young child, showing involvement of pericardium and chest wall, and mediastinal shift. Photo: courtesy of ThatPeskyCommoner.