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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Nutai Biologics Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

male or female, aged 18~75 at the time of signing the ICF;

patient with advanced solid tumors who have failed/cannot tolerate previous standard therapies or lack conventional effective therapies;

at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);

Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;

Disqualifiers

has received any of the anti-tumor treatments below:a) received cytotoxic chemotherapy, tumor immunotherapy, anti-tumor biologics or other trail agents within 4 weeks or 5 half-times (whichever is shorter) before the initial infusion.b)received an oral small-molecule targeted anti-tumor agent within 2 weeks before the first infusion or for five half-lives(whichever was shorter).c) received anti-tumor Chinese patent medicine approved by NMPA within 2 weeks before the initial infusion.d) received more than 30% bone marrow radiotherapy or large area radiotherapy within 2 weeks before initial infusion (palliative radiotherapy at the bone or superficial lesions is acceptable).

participated in and received an investigational drug or device clinical trial within 4 weeks before initial infusion.

Patients who had undergone or planned to undergo major surgery or interventional therapy (excluding tumor biopsy, puncture, etc.) within 4 weeks before initial infusion.

unrecovered from the toxic reaction caused by previous anti-tumor treatment (not recovered to ≤ grade 1 or baseline; not including toxic reactions with no safety risk as determined by the investigator, such as alopecia, asymptomatic hypothyroidism caused by immune checkpoint inhibitors that can be treated with only thyroid hormone and remains stable, and etc.).

Trial design

Treatments tested in this trial

  • SXRN
  • Placebo

Treatment groups

28 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Jiangsu Nutai Biologics Co., Ltd

Lead sponsor

Chinese Academy of Medical Sciences

Collaborator

Jiangsu GQ Pharma Co., Ltd.

Collaborator