Solid Tumor
Conditions
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.
Interventions
BIOLOGICALVRT106
intratumoral injection
Sponsors
Guangzhou Virotech Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
China
Contacts
Primary ContactHongyun Zhao
Outcome results
None listed