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VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. Currently, one phase I dose escalation safety study has been completed in China and the United States respectively, both demonstrating excellent safety profiles with no dose-limiting toxicities (DLTs) observed and no maximum tolerated dose (MTD) identified. Moreover, it has shown preliminary efficacy in treating advanced tumors. Considering the actual clinical needs and the volume of intratumoral administration, a more appropriate recommended phase 2 dose (RP2D) level has been selected for the phase II clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | VG2025 (Recommended Phase II Dose), Intratumoral Injection, Q4W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VG2025 | Drug | Recommended Phase II Dose, Intratumoral Injection, Q4W |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) | up to 36 months |
| DCR | Disease control rate (DCR) | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival (PFS) | up to 36 months |
| OS | Overall Survival (OS) | up to 36 months |
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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 | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Correlation between VG2025 efficacy and CEA levels | Preliminary analysis of the correlation between the efficacy of VG2025 and peripheral blood carcinoembryonic antigen (CEA) levels | up to 36 months |
| Immune-related indicators | Peripheral blood lymphocyte subsets, plasma cytokines, T cell immunity, and other immune-related indicators | up to 36 months |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety will be evaluated according to CTCAE 6.0, including AEs/SAEs during the study, abnormalities or changes in 12-lead ECGs, and laboratory tests. | up to 36 months |
| D009369 | Neoplasms |