AzTrials
AzTrials

Primary Hepatocellular CarcinomaPhase 1/2NCT06124001

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

A Phase 1/2 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) and camrelizumab for Injection in people with Primary Hepatocellular Carcinoma, run by CNBG-Virogin Biotech (Shanghai) Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Hepatocellular Carcinoma
What is being tested?
Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) and camrelizumab for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
30 Nov 2023to 30 Jun 2026
Phase
Phase 1/2
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

  • 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.
  • According to RECIST 1.1, it is determined that at least one CT examination shows that it is measurable and meets the requirements of the volume of injection administration (or the volume of first injection administration in phase IIa) that can be injected under ultrasound guidance (preferably the main tumor burden lesion) under ultrasound guidance, and the longest baseline diameter of the injection lesion (short diameter of lymph node lesions) is >1.5 cm (of which the portal vein lymph node is short, the diameter needs to be > 20 mm).
  • Those with positive herpes simplex virus antibody test results (HSV-1 IgG or HSV-1 IgM).
Show all 15Show fewer
  • ECOG physical status score 0-1.
  • Estimated survival time of more than 3 months.
  • Have adequate organ function:
  • Routine blood (no blood transfusion or colony-stimulating factor therapy within 14 days): ANC≥ 1.5×109/L, PLT≥75×109/L, Hb≥85g/L, lymphocyte count ≥1.5×109/L (for lymphocyte count 0.8×109/L to 1.5×109/L is determined by the investigator whether to enroll);
  • Liver function: TBIL≤1.5×ULN, ALT≤5×ULN, AST≤5×ULN;
  • Child-Pugh A or better B (≤ 7);
  • Renal function: Cr≤1.5×ULN, and creatinine clearance ≥ 45ml/min (calculated according to Cockcroft-Gault formula);
  • Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR) ≤1.5×ULN.
  • Eligible subjects of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier or abstinence) during the trial and at least 90 days after the last dose (VG161 or carrelizumab, whichever occurs later); Female patients of childbearing age must have a negative blood pregnancy test within 7 days prior to enrollment.

Who cannot join

  • 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.
  • Patients who have received systemic corticosteroids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressants within 14 days before the first use of study drugs;Exceptions are the following: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids (≤10 mg prednisone equivalent) for prophylactic treatment (e.g., prevention of contrast media allergy).
  • Have received vaccination within 4 weeks before the first use of study drugs.
Show all 27Show fewer
  • Known severe allergic reaction to any monoclonal antibody.
  • The adverse reactions of previous anti-tumor treatments have not returned to CTCAE 5.0 grade ≤1 (except for toxicities such as hair loss that the researcher has judged to have no safety risks).
  • Liver tumor burden is greater than 50% of the total liver volume, or those who have received liver transplantation in the past.
  • Patients with central nervous system metastasis, spinal cord metastasis and/or spinal cord compression are not suitable for inclusion according to the investigator's judgment.
  • In the period of recurrent infection of herpes simplex virus, with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, genital herpes, etc.
  • Other uncontrolled active infections.
  • Have a history of immunodeficiency, including positive HIV antibody test and positive Treponema pallidum antibody test.
  • Patients with active chronic hepatitis B or active hepatitis C (except hepatitis B virus carriers, stable hepatitis B after drug treatment [negative HBV-DNA test or <50IU/ml] and cured hepatitis C patients [HCV RNA Tested negative]).
  • Have a history of serious cardiovascular and cerebrovascular diseases:
  • Ventricular arrhythmias requiring clinical intervention;
  • QTc interval>480ms;
  • Acute coronary syndrome, congestive heart failure, stroke or other grade III or above cardiovascular events within 6 months;
  • New York Heart Association (NYHA) cardiac function class ≥ class II or left ventricular ejection fraction (LVEF) <40%;
  • Uncontrolled hypertension (systolic blood pressure ≥140mmHg, or diastolic blood pressure ≥90mmHg after treatment).
  • Patients with active or past autoimmune diseases that may relapse (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (including but not limited to these diseases or syndromes, etc.); but does not include patients with clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; Type I diabetes on insulin; patients with vitiligo or childhood asthma/allergies that have resolved and do not require any intervention in adulthood.
  • Have received immunotherapy and experienced immune-related adverse events (irAEs) such as immune-related pneumonia, myocarditis, etc., which may affect the safety of the trial medication as judged by the researcher.
  • Known alcohol or drug dependence.
  • People with mental disorders or poor compliance.
  • Pregnant or lactating women.
  • Patients with obvious symptoms and unstable pleural effusion, peritoneal effusion or pericardial effusion (those with stable clinical symptoms after treatment of pleural effusion, ascites or pericardial effusion can be included).
  • The researcher believes that the subject has other serious systemic diseases or other reasons and is not suitable to participate in this clinical study.

Trial locations and contacts

No sites are listed yet.

Tingbo Liang, MD.PhD. contact

0571-87236666

liangtingbo@zju.edu.cn

Yinan Shen, MD. PhD. contact

0571-87236666

fysyn@163.com

About this study

Official title: An Open-label Phase Ib/IIa Clinical Trial of VG161 Combined With Camrelizumab in the Treatment of Advanced Primary Hepatocellular Carcinoma

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.

Read the detailed description

Part1(Phase Ib primary objective): To evaluate the safety and tolerability of VG161 administered by intratumoral injection combined with camrelizumab in the treatment of patients with advanced advanced primary hepatocellular carcinoma who have received at least one first-line treatment regimen. explore the most suitable recommended Phase II dose (RP2D) for combination therapy, and determine the recommended regimen for combination therapy in Phase IIa clinical trials. Secondary objectives:1) Preliminary evaluation of the anti-tumor activity of VG161 combined with camrelizumab in the treatment of patients with advanced primary hepatocellular carcinoma;2) Monitor changes in immunological indicators related to pharmacodynamics;3) Evaluate the impact of herpes simplex virus type I antibody titer levels on the safety and effectiveness of VG161.

Part2(Phase IIa Primary Objective): To evaluate the efficacy of VG161 in combination with carrelizumab in the treatment of patients with advanced primary hepatocellular carcinoma, the main observation index was objective response rate (ORR). Secondary objectives: 1) secondary observations to evaluate the efficacy of combination therapy, including disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and duration of remission (DOR);2) monitoring changes in pharmacodynamic-related immunological indicators;3) To further evaluate the safety of VG161 in combination with carrelizumab.4) To evaluate the effect of herpes simplex virus type I antibody titer level on the safety and efficacy of VG161

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

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

  • camrelizumab for InjectionDrug

    Also called camrelizumab

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

Study groups in NCT06124001
Study groupRoleWhat they receive
Experimental: Single ArmExperimentalVG161: 1)1.0 × 10 ^ 8 PFU daily for 2 consecutive days on Days 1-2 of each cycle (D1-D2); 2)1.0 × 10 ^ 8PFU daily for 3 consecutive days on Days 1-3 of each cycle (D1-D3); camrelizumab: 3 mg/kg every 3 weeks (D8) Part2: Depends on the recommended dose in Part1
Receives: Drug: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)); Drug: camrelizumab for Injection

What is being measured

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

  1. Phase Ib:RP2D/MTD

    RP2D/MTD for VG161 in Combination with Camrelizumab

    Measured: 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)

    Measured: 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)

    Measured: through Phase Ib study completion, an average of 8 months

  4. Phase IIa:ORR

    Objective response rate (ORR)

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

Secondary outcomes (7)

  1. Phase Ib and Phase IIa:ORR

    Objective response rate (ORR)

    Measured: through Phase Ib and Phase IIa study completion, an average of 2 year

  2. Phase Ib and Phase IIa:DCR

    disease control rate (DCR)

    Measured: through Phase Ib and Phase IIa study completion, an average of 2 year

  3. Phase Ib and Phase IIa:PFS

    Progression Free Survival (PFS)

    Measured: through Phase Ib and Phase IIa study completion, an average of 2 year

  4. Phase Ib and Phase IIa:OS

    Overall Survival (OS)

    Measured: through Phase Ib and Phase IIa study completion, an average of 2 year

  5. Phase Ib and Phase IIa:DOR

    Duration of Response (DOR)

    Measured: through Phase Ib and Phase IIa study completion, an average of 2 year

  6. Phase Ib and Phase IIa: Immunological indicators

    Immunological parameters: peripheral blood lymphocyte subsets (CD3 +, CD4 +, CD8 +, CD4 +/CD8 + ratio, CD19 +,CD16 + CD56 + (NK) cells), cytokines (IL-12, IL-15, IL-6, TNF-α, IFN-γ)

    Measured: through Phase Ib and Phase IIa study completion, an average of 2 year

  7. Phase Ib and Phase IIa: herpes simplex virus type I antibodies

    Titers of herpes simplex virus type I antibodies

    Measured: through Phase Ib and Phase IIa study completion, an average of 2 year

Timeline

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

  1. First posted9 Nov 2023
  2. Study start30 Nov 2023 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06124001
Sponsor's protocol ID
VG161-C203
Status last verified
Nov 2023
First submitted
16 Oct 2023
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) and camrelizumab for Injection in people with Primary Hepatocellular Carcinoma, run by CNBG-Virogin Biotech (Shanghai) Ltd..

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 15 inclusion and 27 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Phase Ib:RP2D/MTD (time frame: through Phase Ib study completion, an average of 8 months). The study lists 4 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 NCT06124001.

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 15 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in