Evaluating VG2025 for patients with 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 Phase 1 open-label clinical trial aims to assess the safety, tolerability, and pharmacokinetics of VG2025, a recombinant human IL12/15 dual-regulated oncolytic HSV-1 injection, in patients with advanced malignant solid tumors that have not responded to standard treatments. The study will utilize a dose-escalation design to identify the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Participants will be monitored for dose-limiting toxicities over a 4-week evaluation period following the initial treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital，Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Tingbo Liang, M.D.，PhD — First Affiliated Hospital of Zhejiang University
• Study coordinator: Yinan Shen
• Email: fysyn@163.com
• Phone: +86-0571-87236666

Similar studies

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

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• MHB009C for adults with 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.