This is a sequential, ascending-dose, multicenter study conducted in patients with refractory solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of DCR-STAT3.
The primary goal of this first-in-human study is to assess the safety and tolerability of DCR-STAT3 in adults with refractory solid tumors. Secondary study goals are to evaluate potential antitumor effects of STAT3 knockdown, as assessed by circulating blood biomarkers indicative of immune activation, as well as any direct impact on tumor size by appropriate imaging and RECIST 1.1 criteria. Antitumor effects will be evaluated for DCR-STAT3 as a monotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
DCR-STAT3 is a sterile, preservative-free solution in WFI that will be diluted in a suitable admixture diluent (0.9% normal saline) prior to IV infusion.
Next Oncology
Dallas, Texas, United States
Next Oncology
San Antonio, Texas, United States
Incidence of adverse events and dose limiting toxicities
safety and tolerability
Time frame: Cycle 1 (8 weeks)
Severity of adverse events
measured according to CTCAE 5.0 criteria
Time frame: Cycle 1 (8 weeks)
Pharmacokinetic (AUC)
Area under the plasma concentration versus time curve
Time frame: Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)
Pharmacokinetic (Urine)
Urinary excretion
Time frame: Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)
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