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Advanced Intrahepatic CholangiocarcinomaPhase 2NCT06746480

Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma

A Phase 2 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in people with Advanced Intrahepatic Cholangiocarcinoma, run by CNBG-Virogin Biotech (Shanghai) Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Intrahepatic Cholangiocarcinoma
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
33 participants
Where
1 siteChina
Study dates
19 Mar 2022to 1 Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 1. Subjects must fully understand and give informed consent to this study before the trial, and voluntarily sign a written informed consent form.
  • 2. aged 18 to 75 years (inclusive), male or female. 3. patients with histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma.
  • 4. According to the Guidelines for the Diagnosis and Treatment of Biliary Malignant Tumors (CSCO), patients must have previously received at least systemic first-line therapy for advanced intrahepatic cholangiocarcinoma and failed, or cannot tolerate treatment. Patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy were counted as having failed first-line treatment if disease progression occurred during chemotherapy or within 6 months after stopping chemotherapy; 5. According to RECIST 1.1 criteria, one or more CT examinations are determined to be measurable and meet the requirements for the volume administered for the first injection, tumor lesions and/or metastases (the injected lesions should preferably be the main tumor burden lesions) that can be injected under ultrasound or CT guidance, and the baseline longest diameter of the injected lesions (lymph node lesions are short diameters) is > 1.5 cm.
  • 6. Herpes simplex virus type I (HSV-1) antibody test results (HSV-1 IgG or HSV-1 IgM) are positive.
  • 7. ECOG performance score 0-1. 8. Expected survival time of more than 3 months. 9.Adequate organ function:
  • 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;
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  • Liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN;
  • Child-Pugh A-B;
  • 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, prothrombin time (PT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN; 10.Eligible patients of childbearing potential (men and women) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose; female patients of childbearing potential must have a negative blood pregnancy test within 7 days prior to enrollment.

Who cannot join

  • 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).
  • 2. Patients who have received transcatheter arterial chemoembolization (TACE) within 4 weeks before the first use of the study drug.
  • 3. Received other clinical trial drugs that are not approved for marketing within 4 weeks before the first use of the study drug.
  • 4. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose of study drug.
  • 5. Have received a vaccine within 4 weeks prior to the first dose of study drug.
  • 6. Patients who have received systemic corticosteroids (prednisone > 10 mg/day or equivalent doses of the same class of drugs) or other immunosuppressive agents within 14 days before the first dose of study drug; except for the following: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term corticosteroids (≤ 10 mg prednisone equivalent) for prophylaxis (e.g., prevention of contrast agent allergy).
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  • 7. The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except alopecia and other toxicities that are judged by the investigator to have no safety risk); 8. Patients with central nervous system metastasis, spinal cord metastasis and/or spinal cord compression.
  • 9. in the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.
  • 10. other active uncontrolled infections. 11. History of immunodeficiency, including positive HIV antibody test and positive Treponema pallidum antibody test.
  • 12. Patients with active chronic hepatitis B or active hepatitis C. (Except hepatitis B virus carriers, hepatitis B virus stable after drug treatment [HBV-DNA negative or < 500 IU/ml] and cured hepatitis C patients [HCV RNA negative]) 13. History of serious cardiovascular disease:
  • 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;
  • New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) < 40%;
  • Uncontrolled hypertension after treatment (judged by the investigator); 14. Patients with active, or have had and have the possibility of relapse of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); except for clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone, type I diabetes treated with stable doses of insulin, vitiligo or recovered childhood asthma/allergy, without any intervention in adults.
  • 15. Having received immunotherapy and have experienced immune-related adverse events (irAEs) such as immune-related pneumonia and myocarditis, which may affect the safety of the investigational drug as judged by the investigator.
  • 16. Known alcohol or drug dependence. 17. Patients with mental disorders or poor compliance. 18. Pregnant or lactating women. 19. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

    Yinan Shen, MD. PhD., fysyn@163.com

    Tingbo Liang, MD. PhD.

    Recruiting

Other trials in China

About this study

Official title: A Single-Arm, Multicenter, Open-Label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma

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).

Read the detailed description

The trial was conducted in two phases, and in the first phase, a total of 20 subjects were enrolled (per efficacy assessment analysis set). If 5 or more of the 20 subjects in Stage I achieve an objective response, i.e., the overall ORR is greater than 4/20, it suggests that the drug warrants further investigation and no additional subjects are required to enter Stage II. If only 1 or no subject out of 20 had an objective response, the trial was stopped, indicating that the trial drug had no apparent effect. Otherwise, continue to enter Stage II, add 13 subjects (as per efficacy evaluation analysis set), and the total number of subjects reaches 33. If 5 or more of 33 subjects achieve objective response, i.e., the overall ORR is greater than 4/33, it indicates that the drug has good anti-tumor efficacy and is worthy of entering confirmatory clinical trials.

Being tested
Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))
Keywords
Advanced intrahepatic cholangiocarcinoma

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 is Days 1 through 3.

Study groups in NCT06746480
Study groupRoleWhat they receive
Single ArmExperimental1.0 × 10^8 PFU/day per cycle, intratumoral injection for 3 consecutive days in 28-day cycles.
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. ORR

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

    Measured: 27 months

Secondary outcomes (10)

  1. PFS

    Evaluate medium Progression Free Survival by iRECIST

    Measured: 27 months

  2. 6-month survival rates (OS rate)

    Evaluate Overall Survival rate

    Measured: 33 months

  3. 6-month overall survival (OS)

    Overall Survival

    Measured: 33 months

  4. 12-month survival rates (OS rate)

    Evaluate Overall Survival rate

    Measured: 39 months

  5. 12-month overall survival (OS)

    Overall Survival

    Measured: 39 months

  6. DOR

    Evaluate Disease Control Rate by iRECIST

    Measured: 27 months

  7. peripheral blood lymphocyte subsets (CD3 +, CD4 +, CD8 +, CD4 +/CD8 + ratio, NK, CD19 +, CD56 + cells)

    Concentration of CD3+, CD4+, CD8+, CD4 +/CD8 + ratio, NK, CD19 +, CD56 + cells

    Measured: 27 months

  8. cytokines (IL-6, TNF-α, IFN-γ)

    Concentration of IL-6, TNF-α, IFN-γ

    Measured: 27 months

  9. T cell-related parameters (PD-L1, PD-1, CD69, CD8 + Ki67high)

    Concentration of PD-L1, PD-1, CD69, CD8 + Ki67high

    Measured: 27 months

  10. Safety indicators：laboratory tests results

    Incidence of abnormal laboratory tests results

    Measured: 27 months

Timeline

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

  1. First posted24 Dec 2024
  2. Study start19 Mar 2022
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion1 Dec 2025 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06746480
Sponsor's protocol ID
VG161-C201
Status last verified
Dec 2024
First submitted
19 Feb 2023
Last updated
24 Dec 2024
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 2 study testing Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in people with Advanced Intrahepatic Cholangiocarcinoma, 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 10 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 24 Dec 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 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?

This study is still under way. Results are not available in the source record yet.

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?

ORR (time frame: 27 months). 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 NCT06746480.

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 24 Dec 2024.

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