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Brief Title: A Study of DCR-STAT3 in Adults With Solid Tumors
Official Title: An Open-label, Phase 1, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-STAT3 in Adults With Refractory Solid Tumors
Study ID: NCT06098651
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Next Oncology, Dallas, Texas, United States
Next Oncology, San Antonio, Texas, United States
Name: John Hanrahan, MD MPH
Affiliation: Dicerna Phamaceuticals, a Novo Nordisk Company
Role: STUDY_DIRECTOR