Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer

StatusUnknown
PhasePhase 1
Started

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Study completion date: Dec 31, 2022 to Dec 31, 2024
    • Eligibility criteria expanded, about 75 words
    • Site contact updated
    • Study description shortened, about 2 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 22, 2021 to Mar 16, 2021
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This phase I study will be conducted in HSV-seropositive subjects with advanced primary liver cancer that are refractory to conventional therapies. This is an open label study and it's divided into two parts. Part 1: This part is ascending dose design to determine the safety and tolerability of VG161 and find recommended dose of VG161. Part 2: This part is extended dose design to determine the effectiveness of VG161.
Trial Details
NCT Number NCT04806464
Lead Sponsor CNBG-Virogin Biotech (Shanghai) Ltd.
Conditions
(from sponsor)		 Primary Liver Cancer
Related terms Carcinoma, Hepatocellular, Liver Neoplasms
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov