This is a single-arm, open-label, dose escalation, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) When Administered Via Intratumoral Injection in patients with advanced solid tumors. The primary purpose of this study is to evaluate the safety and tolerability, the secondary purpose is to evaluate the antitumor activity, immunoreactivity, immunogenicity, pharmacokinetics and virus shedding of RT-01.
This is an investigator initiated , single-arm, open-label, dose escalation clinical pharmacology study of RT-01 as a single agent given via Intratumoral injection in patients with advanced solid tumors. The study is a single agent dose escalation which will use an accelerated and "3+3" design to evaluate escalating doses of RT-01. Total enrollment will depend on the toxicities and/or activity observed, with approximately 6-12 evaluable participants enrolled. A Dose-Limiting Toxicity (DLT) observation period of 4 weeks was established before the entry of the first patient at the next dose level.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Administered by intratumoral injection as single agent.
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, China
RECRUITINGDose Limiting Toxicities (DLT)
Dose-limiting toxicity is defined as an adverse event that is considered to be drug-related and meets one of the Protocol definitions
Time frame: Up to 28 days
Incidence of adverse events
Graded according to the NCI CTCAE version 5.0.
Time frame: Up to 6 months
To evaluate the antitumor activity.
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 Pharmacokinetics characteristics of RT-01
The Cmax of Viral RNA
Time frame: Up to 24 Weeks
The Pharmacokinetics characteristics of RT-01
The Tmax of Viral RNA
Time frame: Up to 24 Weeks
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