A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors
- Registration Number
- NCT06368921
- Lead Sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
- Males and females at 18-75 years of age, inclusive, at the Screening Visit.
- Subjects must have histological or cytological diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
- Have at least one injectable lesion.
- An Eastern Cooperative Oncology Group (ECOG) score of 0-1.
- An estimated survival time of ≥ 12 weeks.
- Subject has received any anti-tumor treatment 4 weeks before using the IMP.
- Subject has received any prior oncolytic viruses or other gene therapies.
- Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
- Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VRT106 VRT106 -
- Primary Outcome Measures
Name Time Method Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106. About 2 years Incidence rate of TEAE
Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels. About 2 years Incidence rate of DLT
- Secondary Outcome Measures
Name Time Method Assess the immunogenicity of intratumoral injection of VRT106. About 2 years Detect the presence of neutralizing antibodies against VRT106, which represent the potency of the neutralizing antibodies, using the PD50 value.
Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106. About 2 years Measure the distribution and shedding of VRT106 following intratumoral injection using qPCR (quantitative polymerase chain reaction) method.
Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators. About 2 years 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.
Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators. About 2 years DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1.
Trial Locations
- Locations (3)
Affiliated Cancer Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Affiliated Cancer Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China