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Safety of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Tumors | Clinical Trials | Clareo Health

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Safety of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Tumors

A Phase I Dose Escalation Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Biological Properties of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Patients With Advanced Malignant Solid Tumors

NCT05914376•Hangzhou Converd Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety, tolerance, pharmacokinetics, and biological properties of recombinant human IL-21-expressing oncolytic vaccinia virus injection (hV01) in patients with advanced solid tumors.

Detailed Description

This is a multi-site, single-arm, open-label, dose-escalation study. It consists of two phases: Part A involves a single-dose escalation, and Part B evaluates the safety and tolerability of multiple doses of hV01. Part A: Dose escalation with four dose levels from 1.0×10\^7 PFU to 8.0×10\^8 PFU. The standard 3+3 dose escalation design will be used to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD). The participants will be observed for dose-limiting toxicities (DLTs) for 28 days after the single dose of the first cycle. Part B: After completion of Part A, the sub-MTD/MAD will be chosen for Part B, which will evaluate the safety and tolerability of hV01 administration at two different frequencies: twice per cycle (on days 1 and 8) and three times per cycle (on days 1, 8, and 15). The standard 3+3 design will also be used for this phase. The first cohort, receiving two doses per cycle, will be observed for DLTs for 35 days after the first dose, while the second cohort, receiving three doses per cycle, will be observed for DLTs for 42 days after the first dose.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signing an informed consent form.
•Men or women aged 18 to 75 years.
•Histologically and/or cytologically confirmed advanced malignant solid 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 medical imaging equipment such as B-ultrasound or CT. 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.
•Life expectancy of at least 3 months.
•Required baseline laboratory data include:
•1. Hematology: absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, platelet (PLT) count ≥ 75×10\^9/L, hemoglobin (Hb) ≥90 g/L (without supportive therapy within 14 days prior to laboratory test);
•2. Liver function: serum total bilirubin (TBIL) ≤1.5×ULN (or ≤3×ULN for patients with Gilbert's syndrome or liver metastasis); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN (or\<5×ULN for patients with primary liver cancer or liver metastasis);
•3. Renal function: serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance (Cockcroft-Gault method) ≥45 mL/min. For men: creatinine clearance = \[\[140-age(yr)\]×weight (kg)\]/\[0.818×creatinine (μmol/L)\]; For women: creatinine clearance = \[\[140-age(yr)\]×weight (kg)×0.85\]/\[0.818×creatinine (μmol/L)\];
+2 more criteria

Exclusion Criteria

•Receiving any of the following anti-tumor treatments within a specified time period:
•1. Systemic anti-tumor treatment, including chemotherapy, large-molecule targeted therapy, immunotherapy, and endocrine therapy within 4 weeks before first dose (within 6 weeks of dosing for nitrosourea or mitomycin C);
•2. Small-molecule targeted therapy within 2 weeks before first dose or within 5 half-lives of the small-molecule targeted drug (whichever is longer);
•3. Traditional Chinese medicine or Chinese herbal medicine used as anti-tumor agent within 2 weeks before first dose;
•4. Radiotherapy (excluding palliative radiotherapy) within 2 weeks before first dose;
•5. Prior oncolytic virus treatment.
•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).
•Previous allogeneic stem cell or organ transplantation.
+9 more criteria

Locations (2)

Zhejiang People's Hospital

Hangzhou, Zhejiang, China

Fudan University Shanghai Cancer Center

Shanghai, China

Key Dates

Start Date

July 5, 2023

Primary Completion Date

July 2, 2025

Completion Date

June 10, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Solid Tumors

Interventions

Recombinant human IL-21-expressing oncolytic vaccinia virus injection

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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: February 27, 2026Data 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.

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Safety of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Tumors

Inclusion Criteria

Exclusion Criteria

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