Spots Global Cancer Trial Database for A Study of XmAb®18087 in Subjects With NET and GIST
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Trial Identification
Brief Title: A Study of XmAb®18087 in Subjects With NET and GIST
Official Title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®18087 in Subjects With Advanced Neuroendocrine and Gastrointestinal Stromal Tumors (DUET-1)
Study ID: NCT03411915
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Phoenix, Arizona, United States
City of Hope Medical Center, Duarte, California, United States
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
Mayo Clinic, Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
James Cancer Center, Columbus, Ohio, United States
University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Contact Details
Name: Zequn Tang, MD, PhD
Affiliation: Senior Medical Director, Clinical Development, Xencor
Role: STUDY_DIRECTOR
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