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Primary Liver CancerPhase 1NCT04806464

Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer

A Phase 1 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in people with Primary Liver Cancer, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Liver Cancer
What is being tested?
Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
16 Mar 2021to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
  • Patients who received systemic treatment with either corticosteroids ( \>10 mg/ daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.
  • Subjects with any ≥Grade 1 toxicity (as per NCI CTC AE Version 5.0) related to prior anti-cancer therapy (except for toxicity that the investigator assessed to be no safety risk, such as alopecia.).
Show all 15Show fewer
  • Subjects with Central Nervous System (CNS) metastasis or meningeal metastasis .
  • Seronegative for Herpes Simplex Virus (HSV) (HSV-1IgG and HSV-1IgM).
  • Subjects with the relapse of HSV infection and relevant clinical manifestations, such as lip herpes, herpes keratitis, herpes dermatitis, and genital herpes.
  • Subjects with other uncontrolled active infections.
  • Known history of immunodeficiency and test positive of human immunodeficiency virus (HIV).
  • History of severe cardiovascular disease:
  • 1)Ventricular arrhythmias requiring clinical intervention; 2)QTc interval \>480 ms; 3)Acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events of III grade or above within 6 months; 4)The cardiac function grade≥II or left ventricular ejection fraction (LVEF) \<50% per the New York Heart Association (NYA); 5)Uncontrolled hypertension.
  • 13. Subjects with active or past autoimmune diseases that are likely to recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); acceptable for patients with clinically stable autoimmune thyroiditis.
  • 14. Previous immunotherapy with an immune-related adverse event (irAE) such as immune-related pneumonia, myocarditis, etc., which, in the judgement of the investigator, may affect the safety of the investigational drug. 15. known to have alcohol or drug dependence. 16. Persons with mental disorders or poor compliance. 17. Pregnant or lactating women. 18. Subjects with any significant unrelated systemic illness that to the investigator's opinion would compromise the subject's eligibility to participate the study.

Trial locations and contacts

1 site in 1 country.

Tingbo Liang, MD.PhD. contact

0571-87236666

liangtingbo@zju.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Nan Yi Shen, MD. PhD., fysyn@163.com

    Tingbo Liang, MD. PhD.

    Recruiting

Other trials in China

About this study

Official title: A Dose Ascending, Open Phase I Clinical Study to Evaluate the Safety, Tolerability , Pharmacokinetics Characteristics and Preliminary Effectiveness of VG161 in Subjects with Advanced Primary Liver Cancer

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.

Read the detailed description

Part 1: This part will be conducted in 5 dose ascending cohorts, including 2 accelerated titration design dose group and 3 dose escalation groups. Descriptive statistics will be used to summarize data.

Part 2: This part will only include the part 1 recommended dose. Hypothesis test and descriptive statistics will be used to summarize data.

Being tested
Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))
Keywords
Liver Cancer
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called VG161

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

Study groups in NCT04806464
Study groupRoleWhat they receive
VG161ExperimentalPart1: 1. 1.0*10^8 PFU on Day 1(1.0×10^8PFU) 2. 1.0*10^8 PFU on Days 1 to 2(2.0×10^8PFU) 3. 1.0*10^8 PFU on Days 1 to 3(3.0×10^8PFU) 4. 1.3*10^8 PFU on Days 1 to 3(4.0×10^8PFU) 5. 1.7*10^8 PFU on Days 1 to 3(5.0×10^8PFU) Part2: Depends on the recommended dose in Part1
Receives: Drug: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part1: MTD/Recommended dose

    MTD (Maximum tolerable dose) /Recommended dose

    Measured: 7 month

  2. Part1: Occurence of DLT

    Occurence of DLT (Dose Limiting Toxicity)

    Measured: 1month

  3. Part1: Numbers of DLT

    Numbers of DLT (Dose Limiting Toxicity)

    Measured: 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）

    Measured: 7 months

  5. Part1: Frequency of AE and SAE（NCI CTCAE 5.0）

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

    Measured: 7 months

  6. Part2:ORR

    Evaluate Objective Response Rate by RECIST 1.1

    Measured: 7 months

Secondary outcomes (20)

  1. Part1:Tmax(h)

    Time to peak

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. Part1:Cmax(copies/ugDNA)

    Maximum concentration

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  3. Part1:ORR

    Evaluate Objective Response Rate by iRECIST

    Measured: 7 months

  4. Part1:DOR

    Evaluate Disease Control Rate by iRECIST

    Measured: 7 months

  5. Part1:PFS

    Evaluate medium Progression Free Survival by iRECIST

    Measured: 7 months

  6. Part1:OS rate

    Evaluate Overall Survival rate

    Measured: 17 months

  7. Part 1:CD3+, CD4+, CD8+

    Concentration of CD3+, CD4+, CD8+

    Measured: 7 months

  8. Part 1:IL15

    Concentration of IL15

    Measured: 7 months

  9. Part 1:PD-L1, PD-1

    Concentration of PD-L1, PD-1

    Measured: 7 months

  10. Part 2:PFS

    Evaluate medium Progression Free Survival by iRECIST

    Measured: 7 months

  11. Part 2:OS rate

    Evaluate Overall Survival rate

    Measured: 17 months

  12. Part 2: OS

    Overall Survival

    Measured: 17 months

  13. Part 2:DOR

    Evaluate Disease Control Rate by iRECIST

    Measured: 7 months

  14. Part 2:Safety indicators：AEs

    Incidence of adverse events (NCI CTCAE 5.0)

    Measured: 7 months

  15. Part 2:Safety indicators：ECOG

    Incidence of abnormal ECOG scores

    Measured: 7 months

  16. Part 2:Safety indicators：12-lead electrocardiograms

    Incidence of abnormal 12-lead electrocardiograms

    Measured: 7 months

  17. Part 2:Safety indicators：laboratory tests results

    Incidence of abnormal laboratory tests results

    Measured: 7 months

  18. Part 2:CD3+, CD4+, CD8+

    Concentration of CD3+, CD4+, CD8+

    Measured: 7 months

  19. Part 2:IL15

    Concentration of IL15

    Measured: 7 months

  20. Part 2:PD-L1, PD-1

    Concentration of PD-L1, PD-1

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2021
  2. Study start16 Mar 2021
  3. Primary completion21 Mar 2022
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04806464
Sponsor's protocol ID
VG161-C102
Status last verified
Sep 2024
First submitted
12 Mar 2021
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shen Y, Bai X, Zhang Q, Liang X, Jin X, Zhao Z, Song W, Tan Q, Zhao R, Jia W, Gu S, Shi G, Zheng Z, Wei G, Wang Y, Fang T, Li Y, Wang Z, Yang Z, Guo S, Lin D, Wei F, Wang L, Sun X, Qin A, Xie L, Qiu Y, Bao W, Rahimian S, Singh M, Murad Y, Shang J, Chu M, Huang M, Ding J, Chen W, Ye Y, Chen Y, Li X, Liang T. Oncolytic virus VG161 in refractory hepatocellular carcinoma. Nature. 2025 May;641(8062):503-511. doi: 10.1038/s41586-025-08717-5. Epub 2025 Mar 19.

    PubMed 40108464

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in people with Primary Liver Cancer, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tingbo Liang, MD.PhD. (0571-87236666, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part1: MTD/Recommended dose (time frame: 7 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04806464, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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