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NCT07522476RecruitingPhase 2

A Clinical Study to Evaluate the Efficacy and Safety of VG2025 in Intrahepatic Cholangiocarcinoma

An Open-label Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of VG2025 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma

Source: ClinicalTrials.gov · Last updated 22 Sept 2026

Brief summary (registry, in English)

VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. Currently, one phase I dose escalation safety study has been completed in China and the United States respectively, both demonstrating excellent safety profiles with no dose-limiting toxicities (DLTs) observed and no maximum tolerated dose (MTD) identified. Moreover, it has shown preliminary efficacy in treating advanced tumors. Considering the actual clinical needs and the volume of intratumoral administration, a more appropriate recommended phase 2 dose (RP2D) level has been selected for the phase II clinical trial.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
1 Apr 2026
Start date
25 Aug 2026
Primary completion date
18 Jan 2028
Lead sponsor
Virogin Biotech Ltd.
NCT number
NCT07522476

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From 25 Aug 2026 to the primary completion date, 18 Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
  • Participants who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.
  • Known alcohol or drug dependence.

Other illness

  • 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.
  • Other active uncontrolled infection.
  • Participants with mental disorders or poor compliance.
  • Participants in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.

Other

  • Women who are pregnant or breastfeeding.

Who the study is looking for

  • Signed written informed consent form.
  • Age 18 to 75 years (inclusive), male or female.
  • Histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma.
  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.