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

NCT05477849 | Recruiting Phase 1

• 1 other identifier: VG201-C101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Malignant Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Level of deoxyribonucleic acid (DNA)

  12 months

• Interleukin level

  12 months

• ORR

  Multiple time points before and after administration

• DCR

  12 months

• PFS

  12 months

Study Arms (1)

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

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

Interventions

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

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

Also known as: VG2025

3+3 design

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Virogin Biotech Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital，Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Study Officials

• Tingbo Liang, M.D.，PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinan Shen

CONTACT

+86-0571-87236666; fysyn@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 28, 2022
• Study Start: August 23, 2022
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)