This is a Phase 1, multiple dose, ascending dose escalation study; to define a MTD/RD and regimen consisting of a first "priming" dose and escalated subsequent doses of XmAb18087; to describe safety and tolerability; to assess PK and immunogenicity; and to preliminarily assess anti-tumor activity of XmAb18087 in subjects with advanced NET or GIST. The study will enroll dosing cohorts to establish a MTD/RD and regimen in subjects with advanced NET or GIST, then enroll additional subjects into separate NET and GIST expansion cohorts to collect additional data on safety and potential efficacy of XmAb18087.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
monoclonal bispecific antibody
Mayo Clinic
Phoenix, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
Determine the safety and tolerability profile of XmAb18087
Treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 84 Days
Identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087
Establishing a safe and tolerable dose of XmAb18087 administered by intravenous (IV) dosing in NET and GIST patients
Time frame: 84 Days
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Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
Stanford Cancer Center
Palo Alto, California, United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern Medicine
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
...and 6 more locations