The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.
This is a Phase 1, open-label, first-in-human (FIH), multiple-dose, dose escalation study with cohort expansion at the RD, designed to evaluate the safety and tolerability of XmAb808 in combination with pembrolizumab. This study will be conducted in 2 parts: Part A (dose escalation) and Part B (cohort expansion).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Monoclonal bispecific antibody
Monoclonal antibody
UCLA Hematology/Oncology
Los Angeles, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Columbia University Irvine Medical Center
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
...and 2 more locations
Incidence of treatment-emergent adverse events (TEAEs)
Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings
Time frame: Up to 5 years
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: 49 days
Measurement of Cmax
Peak plasma concentration (Cmax)
Time frame: Through study completion, Up to 5 years
Measurement of AUCtau
Area under the plasma concentration versus time curve (AUCtau)
Time frame: Through study completion, Up to 5 years
Objective Response Rate
Objective response rate by RECIST 1.1 assessment of CT/MRI imaging, as modified by PCWG3 for participants with prostate cancer
Time frame: Through study completion, Up to 5 years
Progression-free Survival
Progression-free survival by RECIST 1.1 assessment of CT/MRI imaging, as modified by PCWG3 for participants with prostate cancer
Time frame: Through study completion, Up to 5 years
Duration of Response
Duration of Response by RECIST 1.1 assessment of CT/MRI imaging, as modified by PCWG3 for participants with prostate cancer
Time frame: Through study completion, Up to 5 years
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