VG2025: a targeted therapy for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, early-phase study enrolling adults with advanced solid tumors who have exhausted standard therapies. Participants must be HSV-1 seropositive and eligible for intravenous VG2025, which is a recombinant oncolytic HSV-1 engineered to express IL-12/15. The study will assess safety, tolerability, pharmacokinetics, and preliminary efficacy, with the goal of determining a recommended dose for Phase II. It is conducted in a single institution setting under the lead sponsorship of Virogin Biotech Ltd. and aims to establish a safe dosing framework for future trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jia bin Jin
• Email: jjb11501@rjh.com.cn
• Phone: 021-64370045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Early-phase test of RPTR-1-201 for advanced solid tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.