This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
323
tablet
IV infusion
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope
Duarte, California, United States
University of California, Los Angeles JCCC Clinical Research Unit
Los Angeles, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Georgetown - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Safety and Tolerability of FLX475 as a Single Agent and in Combination With Pembrolizumab Measured by the Incidence of Adverse Events, Including Dose-limiting Toxicities and Maximum Tolerated Dose
treatment-emergent adverse events
Time frame: Approximately 18 weeks
Overall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab
Summary of Best Overall Response
Time frame: Through study completion (approximately 2 years)
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Comprehensive Hematology and Oncology, LLC
St. Petersburg, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Louisville Hospital/James Graham Brown Cancer Center
Louisville, Kentucky, United States
...and 25 more locations