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NCT Number: NCT07522476

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.
  • Known alcohol or drug dependence.
  • Participants with mental disorders or poor compliance.
  • Women who are pregnant or breastfeeding.
  • Participants in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.

Treatment and study plan

VG2025

Drug

Recommended Phase II Dose, Intratumoral Injection, Q4W

Primary outcomes

  1. ORR

    Time frame: up to 36 months

    Objective response rate (ORR)

  2. DCR

    Time frame: up to 36 months

    Disease control rate (DCR)

Secondary outcomes

  1. PFS

    Time frame: up to 36 months

    Progression-free survival (PFS)

  2. OS

    Time frame: up to 36 months

    Overall Survival (OS)

  3. Correlation between VG2025 efficacy and CEA levels

    Time frame: up to 36 months

    Preliminary analysis of the correlation between the efficacy of VG2025 and peripheral blood carcinoembryonic antigen (CEA) levels

  4. Immune-related indicators

    Time frame: up to 36 months

    Peripheral blood lymphocyte subsets, plasma cytokines, T cell immunity, and other immune-related indicators

  5. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: up to 36 months

    Safety will be evaluated according to CTCAE 6.0, including AEs/SAEs during the study, abnormalities or changes in 12-lead ECGs, and laboratory tests.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Virogin Biotech Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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