The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.
This is a Phase 1, open-label, multicenter study of KBP-5209 administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. This study is designed to determine the MTD or RP2D and to characterize the safety, tolerability, and PK profile of KBP-5209.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Single oral dose beginning at 20 mg with daily dosing for 28 day cycles.
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Outcome Measure: safety and tolerability, based on the rate of dose-limiting toxicities, toxicity grade, and reversibility of toxicity.
Time frame: 2 Years
Dose-dependency of toxicity based on: dose limiting toxicities; frequency, type, grade, and seriousness, and causality of treatment-emergent adverse events, and laboratory assessments.
Time frame: While undergoing study treatment and up to 30 days after the last dose of KBP-5209
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