Peloton Therapeutics has dosed the first patient in a Phase ll trial investigating the efficacy and safety of PT2977 for the treatment of von Hippel-Lindau (VHL) disease-associated kidney cancer.
VHL is a rare, hereditary cancer syndrome in which patients have a mutation and/or deletion of the tumour suppressor VHL gene and are at risk for the development of multiple tumours, including renal cell cancer. There are currently no approved systemic therapies for VHL disease.
Peloton’s Phase ll open-label, single-group assignment trial intends to enrol 50 patients at various clinical trial centres across the US and Europe.
The trial’s primary objective is to examine the efficacy of PT2977 to treat VHL disease-associated renal tumours as measured by overall response rate.
Its secondary objectives comprise duration of response, time to response, progression free survival, and time to surgery for VHL disease-associated renal tumours.
The trial also aims to evaluate the efficacy of PT2977 in other VHL disease-associated tumour types and its safety and pharmacokinetics.
During the course of the trial, patients will be examined radiologically around every 12 weeks.
Peloton Therapeutics chief medical officer Mohammad Hirmand said: “The safety, pharmacokinetics, and clinical activity that we have observed in a Phase l trial of PT2977 provides insights into its potential to improve outcomes for patients with kidney cancer.”
PT2977 is a once-daily, orally active agent that is capable of blocking hypoxia-inducible factor-2α (HIF-2α).
It previously showed anti-tumour activity with a favourable safety profile in an early stage clinical study in patients with solid tumours.