NCT06746480

Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma

A Single-Arm, Multicenter, Open-Label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: CNBG-Virogin Biotech (Shanghai) Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This trial is a single-agent, single-arm, multicenter, open-label design clinical trial for advanced intrahepatic cholangiocarcinoma who have failed standard therapy. To evaluate the efficacy of VG161 administered by ultrasound or CT-guided intratumoral injection in patients with advanced intrahepatic cholangiocarcinoma, with the primary outcome measure being objective response rate (ORR).

Detailed description

The trial was conducted in two phases, and in the first phase, a total of 20 subjects were enrolled (per efficacy assessment analysis set). If 5 or more of the 20 subjects in Stage I achieve an objective response, i.e., the overall ORR is greater than 4/20, it suggests that the drug warrants further investigation and no additional subjects are required to enter Stage II. If only 1 or no subject out of 20 had an objective response, the trial was stopped, indicating that the trial drug had no apparent effect. Otherwise, continue to enter Stage II, add 13 subjects (as per efficacy evaluation analysis set), and the total number of subjects reaches 33. If 5 or more of 33 subjects achieve objective response, i.e., the overall ORR is greater than 4/33, it indicates that the drug has good anti-tumor efficacy and is worthy of entering confirmatory clinical trials.

Conditions

• Advanced Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))	Intratumoral injection only. The dosing date is Days 1 through 3.

Timeline

• Start date: 2022-03-19
• Primary completion: 2025-09-30
• Completion: 2025-12-01
• First posted: 2024-12-24
• Last updated: 2024-12-24

Locations

1 site across 1 country: China