The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection as a single agent and in combination with ipilimumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
University of Colorado School of Medicine
Aurora, Colorado, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
Time frame: 6 months from study start
Recommended dose
Using maximum tolerated dose to identify the recommended dose for future studies
Time frame: 6 months from study start
Pharmacokinetics measured through plasma concentrations
measured through plasma concentrations
Time frame: 6 months from study start
measurement of CD8-TIL counts
Time frame: 6 months from study start
RNA expression analysis of IFN gamma and immunomodulatory genes
Time frame: 6 months from study start
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Boston, Massachusetts, United States
Columbia University Medical Center-Herbert Irving Pavilion
New York, New York, United States
University of Texas/MD Anderson Cancer Center MD Anderson PSC
Houston, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States