Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma

ConditionAdvanced Intrahepatic Cholangiocarcinoma

Trial statusRecruiting

Trial phasePhase 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 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Blood routine (no blood transfusion or colony-stimulating factor treatment within 14 days): ANC ≥ 1.5 × 109/L, PLT ≥ 75 × 109/L, Hb ≥ 85 g/L;

Liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN;

Child-Pugh A-B;

Disqualifiers

1. received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of the study drug, of which oral fluorouracil and small molecule targeted drugs were within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer).

Ventricular arrhythmia requiring clinical intervention;

QTc interval > 480 ms;

Acute coronary syndrome, congestive heart failure, stroke or other Grade III and above cardiovascular events within 6 months before the first use of study drugs;

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 is Days 1 through 3.

Treatment groups

33 Participants

are divided into 1 treatment group

Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

ORR

Efficacy evaluation endpoint measures will be evaluated according to iRECIST criteria and refer to RECIST 1.1 criteria.

Time frame

27 months

Secondary outcomes

PFS

Evaluate medium Progression Free Survival by iRECIST

Time frame

27 months

6-month survival rates (OS rate)

Evaluate Overall Survival rate

Time frame

33 months

6-month overall survival (OS)

Overall Survival

Time frame

33 months

12-month survival rates (OS rate)

Evaluate Overall Survival rate

Time frame

39 months

Other outcomes

Exploratory Endpoints

Single-cell sequencing was performed on tumor biopsy samples to explore biomarkers predictive of clinical response to VG161.

Time frame

27 months

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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