This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: Part A, dose escalation, and Part B, dose expansion. The study is designed to establish the dosing schedule of XmAb819 including the priming dose(s), the minimum safe and biologically active dose, and the recommended dose (RD); to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC. All eligible subjects will have relapsed or refractory disease after standard therapy.
The purpose of this study is to evaluate the safety and tolerability of intravenous (IV) administration of XmAb®819 in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and active dose.