Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
Kidney Cancer
Unknown Primary
18 Years and older, Male and Female
XmAb819-01 (primary)
NCI-2022-05582
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.
Eligibility
- Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Subjects who have relapsed and refractory ccRCC with evidence of disease progression on standard-of-care therapies
- ECOG performance status of 0 or 1.
- All subjects must have adequate tumor sample available (slides or archival FFPE blocks)
Treatment Sites in Georgia
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