This is a single-arm, open-label, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer. 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 in Patients With Extensive-Stage Small Cell Lung Cancer. 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 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 Extensive-Stage Small Cell Lung Cancer. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravenous injection a single dose of RT-01
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, China
RECRUITINGIncidence of adverse events
Graded according to the NCI CTCAE version 5.0.
Time frame: Up to 6 months
To evaluate the antitumor activity
To assessed per RECIST and iRECIST
Time frame: Up to 2 years
The changes of the immunoreactivity during treatment.
Peripheral blood T lymphocyte subtype
Time frame: Up to 28 days
To evaluate the immunogenicity of RT-01
Antiviral antibody
Time frame: Up to 28 days
To evaluate the viral shedding of RT-01
Viral RNA
Time frame: Up to 24 Weeks
The Cmax of Viral RNA
The maximum RNA peak concentration
Time frame: Up to 24 Weeks
The Tmax of Viral RNA
The time of maximum RNA peak concentration
Time frame: Up to 24 Weeks
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