The primary purpose of this study is to determine whether the combination of the investigational drug XmAb541 in combination with the investigational drug XmAb808 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 in combination with XmAb808 on participants' tumor outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Xencor Investigative Site
Lake Success, New York, United States
RECRUITINGXencor Investigative Site
New York, New York, United States
RECRUITINGXencor Investigative Site
The Bronx, New York, United States
RECRUITINGIncidence of Adverse Events
Time frame: Day 1 to 2 years
Incidence of dose-limiting toxicities
Time frame: Day 1 to Day 43
Measurement of Cmax
Peak Plasma Concentration
Time frame: Day 1 - 2 years
Measurement of area under curve (AUC)
Area under the plasma concentration versus time curve
Time frame: Day 1 to 2 years
Measurement of Ctrough
Plasma concentration before next dose
Time frame: Day 1 to 2 years
Objective Response Rate
Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
Time frame: Day 1 to 2 years
Duration of Response
Duration of Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
Time frame: Day 1 to 2 years
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Xencor Investigative Site
Fort Worth, Texas, United States
RECRUITING