The single-agent, open-label phase I study of CHIR-265 is designed to evaluate the safety, dose tolerability and pharmacokinetic profile of CHIR-265 in patients with melanoma – a type of skin cancer.
According to the company, a translational medicine approach will be used to monitor biomarkers in order to evaluate the biological activity and define the optimal dose. The study is expected to enroll up to 60 patients at three leading cancer centers in the US.
“We are pleased to move forward with clinical study of this exciting new compound,” said Stephen Dilly, chief medical officer, Chiron BioPharmaceuticals. “Malignant melanoma is a promising indication for CHIR-265, given the high percentage of Raf mutations associated with the disease and the need for effective new treatments.”
Preclinical data suggest that CHIR-265 has both direct anti-proliferative/pro-apoptotic activity on tumor cells as well as anti-angiogenic activity that targets the tumor blood supply.