A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of VG2025 Intravenous Injection in Subjects With Advanced Solid Tumors

An Open-label, Multicenter Phase I/IIa Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of VG2025 Intravenous Treatment in Subjects With Advanced Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Malignant Solid Tumor
• Intervention / Treatment: Drug: Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jia bin Jin; Phone Number: +86 18101870031; Email: jjb11501@rjh.com.cn

Study Locations

• China
  • Shanghai, China, 200025
    • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Contact: Bai yong Shen; Phone Number: 13967159109; Email: shenby@shsmu.edu.cn
    • Contact: Email: ziwei.zheng@virogin.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age 18 to 75 years (inclusive); Open to all genders.
2. Phase I: Participants with advanced solid tumors who have failed standard therapy (due to intolerance or disease progression following treatment) as confirmed by histopathology and/or cytology, or for whom no standard therapy is currently approved.
3. Participants must test positive for Herpes Simplex Virus Type 1 (HSV-1) antibodies (HSV-1 IgG or HSV-1 IgM).
4. Within 7 days prior to the first administration of the study drug, female participants of childbearing potential must confirm a negative serum pregnancy test. Participants of childbearing potential and their partners must agree to use effective contraception during the study drug administration period and for 90 days after the last dose.

Exclusion Criteria:

1. Participants experiencing an active herpes simplex virus (HSV) recurrence with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, or genital herpes; or those requiring anti-HSV treatment.
2. Participants who have received anticancer therapy or radiation therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to enrollment.
3. Underwent major surgery (excluding needle biopsy or intravenous catheterization) or interventional/ablation therapy within 4 weeks prior to the first dose.
4. Individuals with addiction to alcohol, drugs, or other substances; participants who have been abstinent for more than 2 years are eligible for en.
5. Any other serious underlying medical conditions, or mental or psychological disorders, hereditary diseases, etc., that, in the investigator's judgment, may interfere with disease staging, treatment, or follow-up; affect the participant's compliance; or place the participant at high risk.
6. Any other circumstances that, in the investigator's judgment, render the participant unsuitable for participation in the clinical trial.

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 42 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; Dose level 6; Dose level 7

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
Safety：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
Level of deoxyribonucleic acid (DNA)	Shedding profile of detectable VG2025 deoxyribonucleic acid (DNA)	12 months
Interleukin level	Evaluate the interleukin-12 (IL-12) and interleukin-12 (IL-15) levels	12 months
DCR	Disease control rate (DCR)	12 months
PFS	Progression-free survival (PFS)	12 months
ORR	Objective response rate (ORR)	12 months
Duration of relief（DOR）	Duration of relief（DOR）	12 months
Immunogenicity Parameters	Incidence of antibodies against VG2025, anti-drug antibodies (ADA) and neutralizing antibodies (NAb)	12 months
Efficacy and Safety of VG2025 and Its Correlation with CEA Levels	A preliminary analysis of the correlation between the efficacy and safety of VG2025 and peripheral blood carcinoembryonic antigen (CEA) levels.	12 months

Collaborators and Investigators

• Sponsor: Virogin Biotech Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 4, 2026
• Primary Completion (Estimated): December 2, 2028
• Study Completion (Estimated): September 3, 2029

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: VG201-IV-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