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VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3+3 design | Experimental | This is an open label, single-arm trial using standard 3+3 design, in up to 42 HSV seropositive subjects. This rule-based design proceeds with cohorts of three patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety:Adverse Events (AEs) and Serious Adverse Events (SAEs) | The assessment is conducted by monitoring the severity of AEs and SAEs during the study, including performing protocol-specified vital signs checks, physical examinations, 12-lead ECGs, laboratory tests, DLTs, and so on. | 12 months |
| MTD/RP2D | Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D) | During the 28 day DLT observation period |
| Measure | Description | Time Frame |
|---|---|---|
| Level of deoxyribonucleic acid (DNA) | Shedding profile of detectable VG2025 deoxyribonucleic acid (DNA) | 12 months |
| Interleukin level | Evaluate the interleukin-12 (IL-12) and interleukin-12 (IL-15) levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia bin Jin | Contact | +86 18101870031 | jjb11501@rjh.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | 200025 | China |
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| 12 months |
| ORR | Objective response rate (ORR) | 12 months |
| Duration of relief(DOR) | Duration of relief(DOR) | 12 months |
| DCR | Disease control rate (DCR) | 12 months |
| PFS | Progression-free survival (PFS) | 12 months |
| Immunogenicity Parameters | Incidence of antibodies against VG2025, anti-drug antibodies (ADA) and neutralizing antibodies (NAb) | 12 months |
| Efficacy and Safety of VG2025 and Its Correlation with CEA Levels | A preliminary analysis of the correlation between the efficacy and safety of VG2025 and peripheral blood carcinoembryonic antigen (CEA) levels. | 12 months |