This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Three-hour IV infusions on Cycle 0 Days 1, 3, 5, and weekly three-hour IV infusions in Cycles 1 and beyond, on Days 1, 8, and 15 of each cycle.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Moores UC San Diego Cancer Center
La Jolla, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Blood and Marrow Transplant Group of Georgia at Northside Hospital
Safety of IONIS-STAT3Rx in patients with Advanced Cancers
Time frame: Approximately 28 days after last dose of IONIS -STAT3Rx
Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers.
Highest dose level at which no more than 1 out of 6 patients develops a DLT
Time frame: Approximately 28 Days
Clinical activity of IONIS-STAT3Rx
Measured by RECIST in the study population who have measurable disease or relevant disease specific response criteria
Time frame: Approximately 28 Days after last dose of IONIS-STAT3Rx
Pharmacokinetics-Cmax
Maximum observed drug concentration (Cmax)
Time frame: Approximately 28 days after last dose of IONIS-STAT3Rx
STAT3 and other biomarkers
The effect of treatment with IONIS-STAT3Rx on phospho-STAT3 and other biomarkers
Time frame: Approximately 28 days after last dose of IONIS-STAT3Rx
Pharmacokinetics - Tmax
Time taken to reach Cmax
Time frame: Approximately 28 days after last dose of IONIS-STAT3Rx
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Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States