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A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma
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).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Xencor Investigative Site
Phoenix, Arizona, United States
Xencor Investigative Site
Duarte, California, United States
Xencor Investigative Site
Sacramento, California, United States
Xencor Investigative Site
New Haven, Connecticut, United States
Xencor Investigative Site
Jacksonville, Florida, United States
Xencor Investigative Site
Atlanta, Georgia, United States
Xencor Investigative Site
Chicago, Illinois, United States
Xencor Investigative Site
Chicago, Illinois, United States
Xencor Investigative Site
Louisville, Kentucky, United States
Xencor Investigative Site
Rochester, Minnesota, United States
Start Date
June 13, 2022
Primary Completion Date
February 1, 2027
Completion Date
December 1, 2028
Last Updated
March 5, 2026
307
ESTIMATED participants
XmAb819
BIOLOGICAL
Lead Sponsor
Xencor, Inc.
NCT06349642
NCT07300241
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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