US-based TRACON Pharmaceuticals has started dosing in the randomised Phase II portion of a clinical trial evaluating an anti-endoglin antibody TRC105 in combination with Inlyta (axitinib), a vascular endothelial growth factor (VEGF) inhibitor, to treat patients with renal cell carcinoma.
TRC105 is a new, clinical stage antibody to endoglin, which is a protein that is over-expressed on proliferating endothelial cells and is vital for angiogenesis, the process of new blood vessel formation.
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Currently, TRC105 is being evaluated in several clinical trials in combination with agents that inhibit angiogenesis by targeting the VEGF pathway.
The company said that dose escalation in the Phase I portion of the clinical trial of TRC105 in combination with Inlyta has been completed and the combination was well-tolerated at the approved dose of Inlyta and the recommended Phase II dose of TRC105.
Progression-free survival is the primary endpoint of the Phase II portion of the multi-centre, open-label, randomised clinical trial.
Around 150 patients are expected to be enrolled at about 20 sites in the US, including sites that conducted the Phase I portion of the clinical trial: Dana Farber Cancer Institute, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Cedars-Sinai Medical Center and the University of Alabama-Birmingham.
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By GlobalDataTRACON president and CEO Charles Theuer said: "Based on our experience in the Phase I portion of the clinical trial, where the combination of TRC105 and Inlyta was well-tolerated with encouraging signs of efficacy, we are moving forward into the Phase II portion of the clinical trial.
"We look forward to working closely with our investigators over the coming months to enrol this important study."
TRC105 is being studied in clinical trials sponsored by both TRACON and the National Cancer Institute to treat multiple solid tumour types in combination with VEGF inhibitors.
Image: Micrograph of the most common type of renal cell carcinoma (clear cell) – on right of the image; non-tumour kidney is on the left of the image. Photo: courtesy of Nephron.
