US-based clinical-stage biopharmaceutical firm Tracon Pharmaceuticals has commenced dosing in its Phase III trial of TRC105 in combination with Votrient (pazopanib) for the treatment of angiosarcoma.
TRC105 is being developed as an antibody to endoglin, a protein over-expressed on proliferating endothelial cells required for the formation of new blood vessels.
The randomised Phase III TRC105 and Pazopanib versus Pazopanib alone in patients with advanced angiosarcoma (TAPPAS) trial will be carried out in approximately 124 patients.
It is being conducted under special protocol assessment (SPA) with the US Food and Drug Administration (FDA) at sites in the US and Europe.
Tracon president and chief executive officer Charles Theuer said: “Angiosarcoma is an aggressive cancer with limited therapeutic options, and we are excited to begin this randomised Phase III clinical trial of TRC105 as a potential therapy for patients with this disease.
"We are encouraged by the activity seen to date in the ongoing Phase II trial of TRC105 in combination with Votrient, and look forward to providing further updates as the TAPPAS trial progresses."
The adaptive design of the trial is claimed to allow flexibility and efficiency to detect signs of the drug's clinical benefits, as well as facilitate sample size re-estimation in up to 200 patients based on interim analysis.
The primary endpoint is progression-free survival and the secondary outcome will measure the overall survival.
The drug is being further evaluated in multiple Phase II trials to treat solid tumours in combination with VEGF inhibitors. It has received orphan designation for the treatment of soft tissue sarcoma in both the US and EU.