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Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma

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

NCT06746480•CNBG-Virogin Biotech (Shanghai) Ltd.

View on ClinicalTrials.gov

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. 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).

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•1. 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;
•2. Liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN;
•3. Child-Pugh A-B;
•4. Renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml/min (calculated according to Cockcroft-Gault formula);
•5. 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.

Exclusion Criteria

•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).
•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:
+7 more criteria

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

March 19, 2022

Primary Completion Date

September 30, 2025

Completion Date

December 1, 2025

Last Updated

December 24, 2024

Enrollment

ESTIMATED participants

Conditions

Advanced Intrahepatic Cholangiocarcinoma

Interventions

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

DRUG

Contacts

Tingbo Liang, MD.PhD.

CONTACT

0571-87236666 liangtingbo@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma

Inclusion Criteria

Exclusion Criteria

Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma

Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)

Calcitriol in Advanced Intrahepatic Cholangiocarcinoma