Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

Active:	Yes
Cancer Type:	Kidney Cancer Unknown Primary	NCT ID:	NCT05433142
Trial Phases:	Phase I	Protocol IDs:	XmAb819-01 (primary) NCI-2022-05582
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Xencor, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05433142

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).

Objectives

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 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. All eligible subjects will have relapsed or refractory disease after
standard therapy.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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