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
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.