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

NCT07682870 | Not Yet Recruiting Phase 1

• 1 other identifier: VG201-IV-C101
• Study Type: interventional
• Target: 42
• 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)

• 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

• MTD/RP2D

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

  During the 28 day DLT observation period

Secondary Outcomes (8)

• Level of deoxyribonucleic acid (DNA)

  12 months

• Interleukin level

  12 months

• ORR

  12 months

• Duration of relief（DOR）

  12 months

• DCR

  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 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

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 6. Dose level 6 7. Dose level 7

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:

• Age 18 to 75 years (inclusive); Open to all genders.
• 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.
• Participants must test positive for Herpes Simplex Virus Type 1 (HSV-1) antibodies (HSV-1 IgG or HSV-1 IgM).
• 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.

You may not qualify if:

• 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.
• Participants who have received anticancer therapy or radiation therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to enrollment.
• Underwent major surgery (excluding needle biopsy or intravenous catheterization) or interventional/ablation therapy within 4 weeks prior to the first dose.
• Individuals with addiction to alcohol, drugs, or other substances; participants who have been abstinent for more than 2 years are eligible for en.
• 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.
• Any other circumstances that, in the investigator's judgment, render the participant unsuitable for participation in the clinical trial.

Sponsors & Collaborators

• Virogin Biotech Ltd.: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Location

Central Study Contacts

Jia bin Jin

CONTACT

+86 18101870031; jjb11501@rjh.com.cn

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: June 24, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): September 4, 2026
• Primary Completion (Estimated): December 2, 2028
• Study Completion (Estimated): September 3, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

CN (1)