The open-label, dose-escalation trial will enroll up to 40 patients at multiple centers in the US who have previously been treated with one or two tyrosine kinase inhibitors (TKIs).
Seattle Genetics research and translational medicine senior vice president Jonathan Drachman said ADCs have the potential to change the way many types of cancer are treated, and the company is evaluating its ADC product candidate, SGN-75, in the Phase Ib trial for patients with CD70-expressing RCC.
"We are encouraged by the preliminary single-agent activity and tolerability demonstrated by SGN-75 in RCC patients and by our preclinical data suggesting synergy between auristatin-containing ADCs and mTOR inhibitors, including everolimus," Drachman added.
The study will evaluate the safety and antitumor activity of SGN-75 in combination with everolimus, an mTOR inhibitor, in patients with CD70-positive metastatic RCC.
The primary endpoint of the trial is safety while the key secondary endpoints include best clinical response, progression-free survival and overall survival.