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

"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."