This is an open-label, dose escalation study of the safety and tolerability of oncolytic virus injection(RT-01) when administered via intratumoral injection in patients with advanced solid tumors. The purpose of this study is to assess the safety and tolerability of RT-01 and to determine the recommended phase 2 dose (RP2D) for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of RT-01.
This is an investigator initiated , open-label, study of RT-01 given via intratumoral (IT) injection as a single agent in participants with advanced solid tumors. The study is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of RT-01. Total enrollment will depend on the toxicities and/or activity observed, with approximately 7-18 evaluable participants enrolled. The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of intratumoral administration of RT-01 as a single agent. Secondary objectives will assess efficacy overall response rate, as well as disease control rate, progression free survival, duration of response, and anti-tumor immune responses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Administered by intratumoral injection for 3 dose cohorts: 1×10\^7 TCID50/mL, 1×10\^8 TCID50/mL and 7×10\^8 TCID50/mL
Wuxi People's Hospital
Wuxi, Jiangsu, China
RECRUITINGDose Limiting Toxicities (DLT)
To define the maximum tolerated dose (MTD) of intratumoral administration of RT-01 injection in humans with malignant tumors.
Time frame: Up to 28 days
Safety and tolerability assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP
Time frame: Up to 6 months
Number of participants with laboratory value abnormalities and/or adverse events
Number of participants with potentially clinically significant laboratory values
Time frame: Up to 6 months
Number of participants with vital sign abnormalities and /or adverse event
Number of participants with potentially clinically significant vital sign values
Time frame: Up to 6 months
Safety assessed by 12- lead electrocardiograms (ECGs) adverse events
12-lead ECGs will be read and assessed locally. Any clinically significant adverse changes on the ECG will be reported as Adverse Events
Time frame: Up to 6 months
To evaluate the efficacy assessed per RECIST and iRECIST
Changes in tumor size and occurrence of metastases was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). And Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
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Time frame: Up to 2 years form first dose of RT-01
Number of Participants With Response
Detection of increased systemic immune Response markers in peripheral blood mononuclear cells
Time frame: at baseline, 2, 4, 7, 14, 28 days after injection
Viral shedding of RT-01 in blood
Viral DNA will be analyzed by quantitative polymerase chain reaction (qPCR).
Time frame: Up to 6 months
Presence of neutralizing antibodies of antidrug antibodies (ADAs) development
To evaluate the immunogenicity of RT-01 given as single agent post injection
Time frame: Up to 6 months