A Phase I Study Evaluating Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of the SXRN Plasmid DNA Technique in patients with advanced solid tumors. This Phase I, open-label, dose-escalation study also investigates pharmacokinetics and preliminary efficacy. The study includes patients who have failed or cannot tolerate standard therapies or lack effective conventional treatments. Additionally, a continuous dosing exploration cohort will assess the safety and efficacy of Shuxinrui Na Injection in patients with cancer-related anorexia-cachexia using a randomized, double-blind, placebo-controlled design. The initial phase tests three doses of SXRN—2 mg, 4 mg, and 10 mg—given intravenously once daily for 5 days followed by 2 days off, in 3-week cycles. Dose adjustments depend on safety and pharmacokinetic results. The exploration cohort involves a 2-week period where patients receive placebo or 4 mg SXRN infusion daily, followed by 2 weeks of open-label 4 mg SXRN treatment for all participants. The study uses a triple-masked design with random assignment to groups. Participants will undergo regular assessments including monitoring of side effects, pharmacokinetics, appetite, physical function, body weight, and quality of life. Researchers will collect laboratory tests and imaging to evaluate tumor response and organ function. The primary outcomes include determining the maximum tolerated dose and effects on appetite and physical function over 12 months, with ongoing safety follow-up. Total participation duration varies based on treatment and follow-up requirements.

A Phase I Study on Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients With Advanced Solid Tumors