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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.
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 |
|---|---|---|
| MTD/RP2D | Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D) | During the 28 day DLT observation period |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs)as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 | 12 months |
| 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 | |
|---|---|---|---|---|
| Yinan Shen | Contact | +86-0571-87236666 | fysyn@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tingbo Liang, M.D.,PhD | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| 12 months |
| ORR | Objective response rate (ORR) | Multiple time points before and after administration |
| DCR | Disease control rate (DCR) | 12 months |
| PFS | Progression-free survival (PFS) | 12 months |
| OS | Overall Survival (OS) | 12 months |
| Antibodies | VG2025 anti-drug antibodies (ADA) and neutralizing antibody (Nab) | 12 months |