Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) In Advanced Pancreatic Cancer

Study Overview

Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Pancreatic Cancer

The main goal of this clinical trial is to preliminary evaluate the efficacy of recombinant human IL-21-expressing oncolytic vaccinia virus injection (hV01) in patients with advanced pancreatic cancer.And the secondary purpose is to evaluate the safety of hV01.

This is a single-site, single-arm, open-label,exploratory phase Ⅱa study. Based on the safety results of the completed phase I clinical trial of hV01 , 8.0x10 ^ 8 PFU was selected as a dose level of the dosage for each administration in this clinical trial, hV01 will be administered with twice per cycle (on day 1 and day 15), efficacy evaluation will be conducted on day 28, and every 28 days as a treatment cycle,during which safety will be observed.

Advanced Pancreatic Cancer

BIOLOGICAL: Recombinant human IL-21-expressing oncolytic vaccinia virus injection

hV01-ITu-202

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-05-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-10
First Submitted that Met QC Criteria 2025-05-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-12
First Posted (ACTUAL) 2025-06-05	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: hV01 intratumoral injection Participants will receive intratumoral injections of hV01 at the dose level of 8.0×10^8 PFU on Day 1 and Day 15 of each treatment cycle.	BIOLOGICAL: Recombinant human IL-21-expressing oncolytic vaccinia virus injection hV01 is a recombinant vaccinia virus with deletions of the viral thymidine kinase (TK) and viral growth factor (VGF) genes and insertion of the human IL-21 gene.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: hV01 intratumoral injection

Participants will receive intratumoral injections of hV01 at the dose level of 8.0×10^8 PFU on Day 1 and Day 15 of each treatment cycle.

BIOLOGICAL: Recombinant human IL-21-expressing oncolytic vaccinia virus injection

hV01 is a recombinant vaccinia virus with deletions of the viral thymidine kinase (TK) and viral growth factor (VGF) genes and insertion of the human IL-21 gene.

Primary Outcome Measures	Measure Description	Time Frame
Anti-tumor activity of hV01: overall response rate (ORR).	To evaluate the overall response rate (ORR) as a measurement of tumor response and disease progression.	From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the end of treatment.
Anti-tumor activity of hV01: disease control rate (DCR).	To evaluate the disease control rate (DCR) as a measurement of tumor response and disease progression.	From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the end of treatment.
Anti-tumor activity of hV01: duration of response (DOR).	To evaluate the duration of response (DOR) as a measurement of tumor response and disease progression.	From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the end of treatment.

Secondary Outcome Measures	Measure Description	Time Frame
Anti-tumor activity of hV01: progression-free survival (PFS).	To evaluate the progression-free survival (PFS) as a measurement of tumor response and disease progression.	From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the end of treatment.
Preliminary efficacy of hV01: overall survival (OS).	To evaluate the overall survival (OS) as a measurement of preliminary efficacy.	From signing informed consent form until the date of death from any cause, assessed up to 2 years after the end of treatment.
To assess the adverse events (AEs) and tolerability of hV01.	To assess the frequency, severity, and nature of adverse events (AEs) of hV01 administered by multiple intratumoral injections by a predetermined dose levels of 8x10^8 PFU. This will be determined by abnormalities or changes in vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, 12-lead electrocardiogram, and laboratory test results.	From informed consent till 28 days after first dose.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Meng Li

Phone Number: +86 18758245778

Email: limeng@converd.com.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Signing an informed consent form.
Men or women aged 18 to 75 years.
Histologically and/or cytologically confirmed advanced malignant advanced pancreatic tumors refractory or failed to respond to standard therapy (including disease progression and/or intolerable toxicities).
At least one measurable lesion according to RECIST v1.1 criteria, which can be injected intratumorally either directly or with the assistance of Endoscopic ultrasound. The baseline longest diameter (shortest diameter for lymph node lesions) of the lesion targeted for injection should be more than 1.5 cm, and the lesion also meets the requirements of the relevant dosing volume.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Required baseline laboratory data include:

Female patients of childbearing age must have a negative serum pregnancy test. Female patients of childbearing age and male patients whose partners are of childbearing age must agree to use medically approved contraceptive measures (hormonal or barrier methods or abstinence) throughout the treatment period and also within 3 months after the last dose of the investigational drug. Male patients must also avoid sperm donation.

Receiving any of the following anti-tumor treatments within a specified time period:

Acute toxic effects from prior treatments not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v5.0) grade 1 or below, except for toxicities deemed safe by the investigator, such as alopecia.
Patients with clinical symptoms of central nervous system (CNS) metastasis or meningeal metastasis, or other evidence indicating that CNS or meningeal metastases are not controlled.
Known or suspected active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and Hashimoto's thyroiditis).
History of severe cardiovascular and cerebrovascular diseases, including:

Any uncontrolled active infection requiring systemic anti-infective therapy (graded 2 or higher according to CTCAE v5.0), including but not limited to active tuberculosis, sepsis, bacteremia, fungemia, and viremia.
Any of the following infections: human immunodeficiency virus (HIV), syphilis spirochete(TP), active hepatitis C (positive HCV RNA test) or active hepatitis B (positive HBsAg and HBV DNA ≥ 2000 IU/mL or ≥10^4 copies/mL).
Use of immunomodulatory drugs within 2 weeks of dosing, including but not limited to thymosin, interleukin, interferon.
Pregnant or lactating women.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Xiaofeng Zhang, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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