To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors.
This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of IT injections of VRT106 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of VRT106 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of VRT106, and preliminarily exploring the anti-tumor effects of VRT106.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
intratumoral injection
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGAffiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGAffiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGEvaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106.
Incidence rate of TEAE
Time frame: About 2 years
Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
Incidence rate of DLT
Time frame: About 2 years
Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106.
Measure the distribution and shedding of VRT106 following intratumoral injection using qPCR (quantitative polymerase chain reaction) method.
Time frame: About 2 years
Assess the immunogenicity of intratumoral injection of VRT106.
Detect the presence of neutralizing antibodies against VRT106, which represent the potency of the neutralizing antibodies, using the PD50 value.
Time frame: About 2 years
Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators.
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1.
Time frame: About 2 years
Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators.
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1.
Time frame: About 2 years
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