Advanced Solid Tumor Clinical Trial
Official title:
A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of Oncolytic Virus Injection (RT-01) in Patients With Advanced Solid Tumors
This is a single-arm, open-label, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01.
This is an investigator initiated , single-arm, open-label clinical pharmacology study of RT-01 as a single agent given via Intravenous injection with or without Intratumoral injection in patients with advanced solid tumors. RT-01 will be administered as a single dose on day 1 in patients with advanced solid tumors. Durvalumab will be administered intravenously every 3 weeks starting on day 5 Patient with small-cell lung cancer after RT-1 on day 1 for 4 cycles,then followed by every 4 weeks. This study is planned to enroll 10-20 patients with advanced solid tumors. Considering the benefits of the subjects, the investigator deems that higher doses can be explored, then a higher-dose cohort will be carried out. The purpose of this study is to assess the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01. ;
NCT number | NCT05205421 |
Study type | Interventional |
Source | First Affiliated Hospital Bengbu Medical College |
Contact | zhou huan, MD |
Phone | 13665527160 |
[email protected] | |
Status | Recruiting |
Phase | Phase 1 |
Start date | January 18, 2022 |
Completion date | January 2024 |
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