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RecruitingNCT05477849Updated Apr 1, 2025

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with Solid Tumors

A Phase 1 interventional study of Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection in Advanced Malignant Solid Tumor, sponsored by Shanghai Virogin Biotech Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Shanghai Virogin Biotech Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Aug 2022; still recruiting 4 years 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Advanced Malignant Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Shanghai Virogin Biotech Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed written informed consent form.
  2. Age 18 to 75 years (inclusive), male or female.
  3. Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage.
  4. Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
  2. Subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.
  3. In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.
  4. Other active uncontrolled infection.
  5. Known alcohol or drug dependence.
  6. Subjects with mental disorders or poor compliance.
  7. Women who are pregnant or breastfeeding.
  8. Subjects in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    3+3 design

    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

    Drug: Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection

Interventions

  • DrugRecombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection

    1. Dose level 1 2. Dose level 2 3. Dose level 3 4. Dose level 4 5. Dose level 5

    Also known as: VG2025

06

What researchers measure

Primary outcomes

  1. MTD/RP2D

    Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)

    Time frame: During the 28 day DLT observation period

  2. 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

    Time frame: 12 months

Secondary outcomes

  1. Level of deoxyribonucleic acid (DNA)

    Shedding profile of detectable VG2025 deoxyribonucleic acid (DNA)

    Time frame: 12 months

  2. Interleukin level

    Evaluate the interleukin-12 (IL-12) and interleukin-12 (IL-15) levels

    Time frame: 12 months

  3. ORR

    Objective response rate (ORR)

    Time frame: Multiple time points before and after administration

  4. DCR

    Disease control rate (DCR)

    Time frame: 12 months

  5. PFS

    Progression-free survival (PFS)

    Time frame: 12 months

  6. OS

    Overall Survival (OS)

    Time frame: 12 months

  7. Antibodies

    VG2025 anti-drug antibodies (ADA) and neutralizing antibody (Nab)

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital，Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310003, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05477849
Lead sponsor
Shanghai Virogin Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Jul 28, 2022
Start date
Aug 23, 2022
Primary completion
Oct 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 1, 2025

Study contacts

Yinan Shen
Contact
fysyn@163.com
+86-0571-87236666
Tingbo Liang, M.D.，PhD
principal investigator · Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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