Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer
ConditionPrimary Liver Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCNBG-Virogin Biotech (Shanghai) Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
According to 'The Diagnostic and Therapeutic Criteria for Primary Liver Cancer' (NMPA, 2019 Edition), subject with advanced primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, combined hepatocellular which is refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists. For the second stage of Simon's two-stage in part 2, only patients with advanced primary hepatocellular carcinoma will be enrolled.
There are tumor lesions intrahepatic and / or extrahepatic metastases that can be injected under B ultrasound and meet the volume requirements of the current dose group, and the longest diameter of injectable tumor lesion >1.5cm（or the shortest diameter of lymph node lesions）
Eastern Cooperative Oncology Group (ECOG) scores 0 or 1.
Life expectancy is at least 3 months.
Disqualifiers
Subject in prior anti-tumor therapies such as chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy within 4 weeks of study treatment initiation. Oral fluorouracil analogues and small molecule targeted drugs were 2 weeks prior to the first dose of study drug or within 5 half-lives of the drug (whichever was longer).
Transcatheter arterial chemoembolization(TACE) within 4 weeks of study treatment initiation
Participation in clinical trials of any other investigational agents within 4 weeks of study treatment initiation.
Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks of study treatment initiation.
Trial design
Treatments tested in this trial
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))
Treatment groups
44 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov