VG2025 in intrahepatic cholangiocarcinoma

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 a Phase 2 interventional study evaluating VG2025, a recombinant HSV-1 oncolytic therapy with dual-regulated IL-12/15 expression, delivered intratumorally. Prior Phase I dose-escalation data in China and the US indicated strong safety and early signs of activity, with no dose-limiting toxicities or maximum tolerated dose identified. The trial aims to determine an RP2D and further assess anti-tumor activity in patients with histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma. Eligible participants are adults 18–75 who consent, meet disease criteria, and agree to contraception where applicable; key exclusions include recent unlisted drug therapy, major organ surgery, or active herpes-related infections. The study is sponsored by Virogin Biotech Ltd. and conducted at The First Affiliated Hospital, Zhejiang University School of Medicine (Hangzhou).

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. Histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma.
4. Eligible participants of childbearing participants(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. Participants who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
2. Participants 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. Participants with mental disorders or poor compliance.
7. Women who are pregnant or breastfeeding.
8. Participants 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

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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.