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Clinical Study of VG161 Combined With Camrelizumab in Patients With Advanced Primary Hepatocellular Carcinoma

ConditionPrimary Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
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 injection.This study will be conducted in combination with camrelizumab in patients with advanced advanced primary hepatocellular carcinoma who have received at least one first-line treatment regimen. This is an open-label study divided into two parts.

Part 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination.

Part 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.

Age 18 to 75 (inclusive), gender is not limited.

Patients with advanced primary hepatocellular carcinoma confirmed by histopathology or cytology.

According to the CSCO Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition), patients who have received at least previous first-line treatment regimens that have failed treatment (disease progression or inability to tolerate treatment) must have been treated.

Disqualifiers

Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma or mixed hepatocellular carcinoma.

Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of study drugs, among which oral fluorouracils and small molecule targeted drugs are the first use of study drugs. Within the first 2 weeks or the 5 half-lives of the drug (whichever is longer).

Have received other unmarketed clinical trial treatments within 4 weeks before using the study drug for the first time.

Have undergone major organ surgery (excluding puncture biopsy) or experienced significant trauma within 4 weeks before taking the study drug for the first time.

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. Dosing days may be Days 1-2 or Days 1-3.

  • camrelizumab for Injection

    Drug

    Administered once at 3 mg/kg intravenously on Days 8 of each cycle.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Experimental: Single ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase Ib:RP2D/MTD

RP2D/MTD for VG161 in Combination with Camrelizumab

Time frame
through Phase Ib study completion, an average of 8 months
2

Phase Ib:Incidence and number of DLT

Incidence and number of DLT (dose-limiting toxicity)

Time frame
through Phase Ib study completion, an average of 8 months
3

Phase Ib:AE, SAE occurrence and frequency

Occurrence and frequency of AE (Adverse Event) and SAE（Serious adverse event)

Time frame
through Phase Ib study completion, an average of 8 months
4

Phase IIa:ORR

Objective response rate (ORR)

Time frame
Time Frame: through Phase IIa study completion, an average of 1 year

Secondary outcomes

1

Phase Ib and Phase IIa:ORR

Objective response rate (ORR)

Time frame
through Phase Ib and Phase IIa study completion, an average of 2 year
2

Phase Ib and Phase IIa:DCR

disease control rate (DCR)

Time frame
through Phase Ib and Phase IIa study completion, an average of 2 year
3

Phase Ib and Phase IIa:PFS

Progression Free Survival (PFS)

Time frame
through Phase Ib and Phase IIa study completion, an average of 2 year
4

Phase Ib and Phase IIa:OS

Overall Survival (OS)

Time frame
through Phase Ib and Phase IIa study completion, an average of 2 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

CNBG-Virogin Biotech (Shanghai) Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: