Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))

    Drug

    Intratumoral injection only. The dosing date can be the Day 1 only or Days 1 through 5.

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: VG161Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part1: MTD/Recommended dose

MTD (Maximum tolerable dose) /Recommended dose

Time frame
7 month
2

Part1: Occurence of DLT

Occurence of DLT (Dose Limiting Toxicity)

Time frame
1month
3

Part1: Numbers of DLT

Numbers of DLT (Dose Limiting Toxicity)

Time frame
1 month
4

Part1: Occurence of AE and SAE（NCI CTCAE 5.0）

Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）

Time frame
7 months

Secondary outcomes

1

Part1:Tmax(h)

Time to peak

Time frame
At the end of Cycle 1 (each cycle is 28 days)
2

Part1:Cmax(copies/ugDNA)

Maximum concentration

Time frame
At the end of Cycle 1 (each cycle is 28 days)
3

Part1:ORR

Evaluate Objective Response Rate by iRECIST

Time frame
7 months
4

Part1:DOR

Evaluate Disease Control Rate by iRECIST

Time frame
7 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CNBG-Virogin Biotech (Shanghai) Ltd.

Lead sponsor

Source ClinicalTrials.gov
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