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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intrahepatic Cholangiocarcinoma
• Intervention / Treatment: Drug: VG2025

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yinan Shen; Phone Number: +86-0571-87236666; Email: fysyn@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital，Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; VG2025 (Recommended Phase II Dose), Intratumoral Injection, Q4W	Drug: VG2025; Recommended Phase II Dose, Intratumoral Injection, Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate (ORR)	up to 36 months
DCR	Disease control rate (DCR)	up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-free survival (PFS)	up to 36 months
OS	Overall Survival (OS)	up to 36 months
Correlation between VG2025 efficacy and CEA levels	Preliminary analysis of the correlation between the efficacy of VG2025 and peripheral blood carcinoembryonic antigen (CEA) levels	up to 36 months
Immune-related indicators	Peripheral blood lymphocyte subsets, plasma cytokines, T cell immunity, and other immune-related indicators	up to 36 months
Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	up to 36 months

Collaborators and Investigators

• Sponsor: Virogin Biotech Ltd.
• Investigators: Principal Investigator: Tingbo Liang, M.D.，PhD, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 18, 2028
• Study Completion (Estimated): November 13, 2028

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Cholangiocarcinoma
• Other Study ID Numbers: VG201-C201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No