Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
Start Date
6/13/2022
Completion Date
12/1/2028
Summary
The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).
Detailed Description
This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: dose escalation, and dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC and other solid tumors. All eligible subjects will have relapsed or refractory disease after standard therapy.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
XmAb819
Conditions
Locations
Xencor Investigative Site
Phoenix, Arizona 85054
United States
Xencor Investigative Site
Duarte, California 91010
United States
Xencor Investigative Site
Sacramento, California 95817
United States
Xencor Investigative Site
New Haven, Connecticut 06520
United States
Xencor Investigative Site
Jacksonville, Florida 32224
United States
Xencor Investigative Site
Atlanta, Georgia 30322
United States
Xencor Investigative Site
Chicago, Illinois 60611
United States
Xencor Investigative Site
Chicago, Illinois 60637
United States
Xencor Investigative Site
Louisville, Kentucky 40207
United States
Xencor Investigative Site
Rochester, Minnesota 55905
United States
Xencor Investigative Site
New Brunswick, New Jersey 088901
United States
Xencor Investigative Site
New York, New York 10032
United States
Xencor Investigative Site
New York, New York 10065
United States
Xencor Investigative Site
Charlotte, North Carolina 28777
United States
Xencor Investigative Site
Durham, North Carolina 27710
United States
Xencor Investigative Site
Cincinnati, Ohio 45267
United States
Xencor Investigative Site
Columbus, Ohio 43210
United States
Xencor Investigative Site
Oklahoma City, Oklahoma 73104
United States
Xencor Investigative Site
Nashville, Tennessee 37203
United States
Xencor Investigative Site
Seattle, Washington 98109
United States
Xencor Investigative Site
Leuven, 3000
Belgium
Xencor Investigative Site
Bourdeaux, 33075
France
Xencor Investigative Site
Villejuif, 94805
France
Xencor Investigative Site
Barcelona, 08035
Spain
Xencor Investigative Site
Madrid, 28050
Spain
Xencor Investigative Site
Cambridge, Cambridgeshire CB2 0QQ
United Kingdom