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VG2062 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 VG2062, and recommended dose of VG2062 for Phase II trials.
This is a Phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. The trial will be conducted in multiple dosing cohorts, and evaluated for safety to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). Dose limiting toxicity (DLT) evaluation period is for 4 weeks from the start of treatment Day 1 through Day 28.
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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 30 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 VG2062 deoxyribonucleic acid (DNA) | 12 months |
| ORR | Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu hang Wang | Contact | 13581809307 | wangshuhang@cicams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ning Li, M.D.,PhD | No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province | Recruiting | Hebei | China |
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| 12 months |
| DoR | Duration of relief(DoR) | 12 months |
| DCR | Disease control rate (DCR) | 12 months |
| PFS | Progression-free survival (PFS) | 12 months |
| OS | Overall Survival (OS) | 12 months |
| Antibodies | VG2062 anti-drug antibodies (ADA) and neutralizing antibody (Nab) | 12 months |