The purpose of this clinical trial is to evaluate the safety and tolerability of SXRN Plasmid DNA Technique in patients with advanced solid tumors.
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;
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.).
Sequential
SXRN
DrugSXRN is a naked plasmid DNA drug targeting miRNA.
Placebo
DrugMatching placebo, same dosing regimen (IV infusion once daily for 14 days)
Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE) of SXRN
To determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE) of SXRN in the treatment of advanced solid tumors
Effect for SXRN on Appetite compared to placebo
measured by FAACT-A/CS-12 score; For the expansion cohort only.
Effect of SXRN on physical function compared to placebo
measured by 6MWT; For the expansion cohort only
Pharmacokinetic parameters of SXRN
Maximum plasmid Concentration \[Cmax\]
Preliminary anti-tumor efficacy of SXRN
Anti-tumor activity: objective remission rate (ORR), duration of remission (DOR), disease control rate (DCR), time to remission (TTR) and progression free survival (PFS) basing on RECIST v1.1; overall survival (OS);
Weight improvement of SXRN in patients with advanced solid tumors
Body weight
Appetite improvement of SXRN in patients with advanced solid tumors
Change in patient's quality of life on the FAACT-A/ CS-12 questionnaire (score)
the SXRN transcripts,its targets, and possible regulated targets
Explore the expression changes of the following indicators:the SXRN transcripts 1-RNA, Its targets -miR-214, possible regulated targets-A2AR, INSL3, and Inflammatory Biomarkers
Effect for SXRN on pain compared to placebo
measured by NRS and and analgesic use; For the expansion cohort only
Effect for SXRN on sleep quality compared to placebo
measured by PSQI; For the expansion cohort only
Effect for SXRN on bowel function compared to placebo
measured by BSFS; For the expansion cohort only
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Jiangsu Nutai Biologics Co., Ltd
Lead sponsor
Chinese Academy of Medical Sciences
Collaborator
Jiangsu GQ Pharma Co., Ltd.
Collaborator
