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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
307
Monoclonal Bispecific Antibody
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)
Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS
Time frame: 28 days
Incidence of dose limiting toxicities (DLTs)
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.
Time frame: 28 days
Measurement of Cmax
Peak plasma concentration (Cmax)
Time frame: 56 days
Measurement of AUCtau
Area under the plasma concentration versus time curve (AUCtau)
Time frame: 56 days
Objective Response rate
Objective response rate (RECIST 1.1 assessment of CT/MRI imaging)
Time frame: 42 days
Progression-free survival
Progression-free survival (RECIST 1.1 assessment of CT/MRI imaging)
Time frame: 42 days
Duration of response
Duration of response (RECIST 1.1 assessment of CT/MRI imaging)
Time frame: 42 days
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Xencor Investigative Site
Phoenix, Arizona, United States
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Duarte, California, United States
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Sacramento, California, United States
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New Haven, Connecticut, United States
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Jacksonville, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Louisville, Kentucky, United States
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Rochester, Minnesota, United States
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