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Recruiting NCT05477849

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

Phase I Interventional Advanced Malignant Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection.
Who it may be relevant to
Registry conditions: Advanced Malignant Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Dose Escalation, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in the Treatment of Patients with Advanced Malignant Solid Tumors

Overview

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.

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.

Interventions

  • Drug Recombinant 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

Primary outcome measures

  • MTD/RP2D [Time frame: During the 28 day DLT observation period]
  • Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: 12 months]
Secondary outcome measures (7)
  • Level of deoxyribonucleic acid (DNA) [Time frame: 12 months]
  • Interleukin level [Time frame: 12 months]
  • ORR [Time frame: Multiple time points before and after administration]
  • DCR [Time frame: 12 months]
  • PFS [Time frame: 12 months]
  • OS [Time frame: 12 months]
  • Antibodies [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Signed written informed consent form.
  • Age 18 to 75 years (inclusive), male or female.
  • Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage.
  • 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

  • Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
  • Subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.
  • 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.
  • Other active uncontrolled infection.
  • Known alcohol or drug dependence.
  • Subjects with mental disorders or poor compliance.
  • Women who are pregnant or breastfeeding.
  • Subjects in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital，Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT05477849 · VG201-C101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗