A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2062 in Patients With Solid Tumors

An Open-label, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Biological Effects of VG2062 in Patients With Advanced Solid Tumors.

VG2062 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 VG2062, and recommended dose of VG2062 for Phase II trials.

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Solid Tumor
• Intervention / Treatment: Drug: Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shu hang Wang; Phone Number: 13581809307; Email: wangshuhang@cicams.ac.cn

Study Locations

• China
  • Hebei, China
    • Recruiting
    • No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province
    • Contact: Ning Li; Phone Number: +86 01087788165; Email: lining@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Dose level 1; Dose level 2; Dose level 3; Dose level 4; Dose level 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	The assessment is conducted by monitoring the severity of AEs and SAEs during the study, including performing protocol-specified vital signs checks, physical examinations, 12-lead ECGs, laboratory tests, DLTs, and so on.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DCR	Disease control rate (DCR)	12 months
PFS	Progression-free survival (PFS)	12 months
OS	Overall Survival (OS)	12 months
Level of deoxyribonucleic acid (DNA)	Shedding profile of detectable VG2062 deoxyribonucleic acid (DNA)	12 months
ORR	Objective response rate (ORR)	12 months
DoR	Duration of relief（DoR）	12 months
Antibodies	VG2062 anti-drug antibodies (ADA) and neutralizing antibody (Nab)	12 months

Collaborators and Investigators

• Sponsor: Shanghai Virogin Biotech Co., Ltd.
• Investigators: Principal Investigator: Ning Li, M.D.，PhD, No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: VG203-C101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No