Aravive receives IND clearance for Phase 1b/Phase 2 trial of AVB-500
Aravive announced that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug application for investigation of the company's lead candidate, AVB-500, for the treatment of clear cell renal cell carcinoma. The study has a Phase 1b safety portion and a Phase 2 randomized, controlled portion. The Phase 1b portion will investigate the safety and tolerability of escalating doses of AVB-500 in combination with cabozantanib in patients with advanced clear cell renal cell carcinoma that have progressed with or were intolerant to front-line treatment. The primary endpoints for the Phase 1b portion of the clinical trial are safety, pharmacokinetic and pharmacodynamic measurements with secondary endpoints including preliminary activity measures. The Phase 2 portion of the study will investigate the recommended AVB-500 dose identified during the Phase 1b portion in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma that have progressed with or were intolerant to front-line treatment. The primary endpoint will be progression free survival. The clinical trial will also explore AVB-500 effects on biomarkers (GAS6) in serum.