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

NCT07522476 | Not Yet Recruiting Phase 2

• 1 other identifier: VG201-C201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective response rate (ORR)

  up to 36 months

• DCR

  Disease control rate (DCR)

  up to 36 months

Secondary Outcomes (5)

• PFS

  up to 36 months

• OS

  up to 36 months

• Correlation between VG2025 efficacy and CEA levels

  up to 36 months

• Immune-related indicators

  up to 36 months

• Adverse Events (AEs) and Serious Adverse Events (SAEs)

  up to 36 months

Study Arms (1)

Single Arm

EXPERIMENTAL

VG2025 (Recommended Phase II Dose), Intratumoral Injection, Q4W

Drug: VG2025

Interventions

VG2025 DRUG

Recommended Phase II Dose, Intratumoral Injection, Q4W

Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virogin Biotech Ltd.: lead

Study Sites (1)

The First Affiliated Hospital，Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Tingbo Liang, M.D.，PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinan Shen

CONTACT

+86-0571-87236666; fysyn@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 18, 2028
• Study Completion (Estimated): November 13, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)