NCT06736275

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Jiangsu Nutai Biologics Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the safety and tolerability of SXRN Plasmid DNA Technique in patients with advanced solid tumors.

Detailed description

This is a Phase I, open-label, dose-escalation study to investigate the safety, tolerability, pharmacokinetics and preliminary efficacy of SXRN Plasmid DNA Technique in patients with advanced solid tumors. Three dose levels are initially formulated, namely 2mg, 4mg, and 10mg of SXRN, adopting an accelerated titration followed by the traditional "3+3" design. SXRN will be administered daily x 5 with 2 days off (total of 21 days) for 3 weeks followed by a no-treatment observation period.

Conditions

• Advanced Cancer
• Cachexia

Interventions

Type	Name	Description
DRUG	SXRN	SXRN is a naked plasmid DNA drug targeting miRNA. Accelerated titration and "3+3" dose escalation:In light of ethical considerations and with the aim of minimizing the number of patients possibly exposed to potentially ineffective doses, an "accelerated titration" strategy will be implemented in the early dose escalation phase (2 mg dose group) in this study, with only 1 subject enrolled. If no DLT occurs to the 3 subjects under the given dose in the DLT valuation window (the 1st cycle, 3 weeks), the study will proceed to the next dose (dose escalation in the same subject is not allowed); if one subject develops DLT, 3 additional subject s will be included to the current dose group; if ≥2 DLTs occur in the dose group with 3 or 6 subject s, the dose escalation will be stopped. The decision is made by discussion among the investigators whether to terminate the escalation or consider adjusting the dose for exploration.

Timeline

• Start date: 2024-09-02
• Primary completion: 2025-10-06
• Completion: 2025-10-09
• First posted: 2024-12-16
• Last updated: 2026-04-03

Locations

1 site across 1 country: China