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Brief Title: Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors
Official Title: A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors
Study ID: NCT05585034
Brief Summary: 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.
Detailed Description: 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States
Froedtert Hospital & The Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Chet Bohac, MD
Affiliation: Xencor, Inc.
Role: STUDY_DIRECTOR