The primary purpose of this study is to determine whether the investigational drug XmAb541 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 on tumor outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
282
Monoclonal bispecific antibody
City of Hope
Duarte, California, United States
Incidence of adverse events
Time frame: Day 1 to 2 years
Incidence of dose-limiting toxicities (DLTs)
Time frame: Day 1 to Day 28
Incidence of cytokine release syndrome (CRS)
Time frame: Day 1 to Day 28
Measurement of Cmax
Peak plasma concentration
Time frame: Day 1 to 2 years
Measurement of area under curve (AUC)
Area under the plasma concentration versus time curve
Time frame: Day 1 to 1.4 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 Response Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
Time frame: Day 1 to 2 years
Changes in Circulating Tumor DNA (ctDNA)
Maximum variant frequency or mean/median variant frequency
Time frame: Day 1 to 4 months
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