Advanced Solid TumorsPhase 1NCT05914376

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

A Phase 1 study testing Recombinant human IL-21-expressing oncolytic vaccinia virus injection in people with Advanced Solid Tumors, run by Hangzhou Converd Co., Ltd. at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Solid Tumors
What is being tested?: Recombinant human IL-21-expressing oncolytic vaccinia virus injection
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesChina
Study dates: 5 Jul 2023to 10 Jun 2027
Phase: Phase 1
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

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.

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Required baseline laboratory data include:
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);
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);
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)];
Coagulation test: activated partial thromboplastin time (APTT) ≤1.5×ULN; international normalized ratio (INR) ≤1.5×ULN.
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.

Who cannot join

Receiving any of the following anti-tumor treatments within a specified time period:
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);
Small-molecule targeted therapy within 2 weeks before first dose or within 5 half-lives of the small-molecule targeted drug (whichever is longer);
Traditional Chinese medicine or Chinese herbal medicine used as anti-tumor agent within 2 weeks before first dose;
Radiotherapy (excluding palliative radiotherapy) within 2 weeks before first dose;
Prior oncolytic virus treatment.

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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.
History of severe cardiovascular and cerebrovascular diseases, including:
Acute coronary syndrome (including myocardial infarction, severe or unstable angina), myocarditis, congestive heart failure, cerebrovascular accidents, or other cardiovascular events of CTCAE (v5.0) grade 3 or higher within 12 months of dosing;
Severe arrhythmia requiring clinical intervention (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes), corrected QT interval (QTc) >450 ms for males or >470 ms for females, or a family history of long QT syndrome;
New York Heart Association (NYHA) classification of class II or above, or left ventricular ejection fraction (LVEF) <50%;
Uncontrolled hypertension (as judged by the investigator) or hypotension despite standard treatment.
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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Zhejiang People's Hospital
Hangzhou, Zhejiang
Fudan University Shanghai Cancer Center
Shanghai

Other trials in China

About this study

Official title: 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

Read the 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.

Conditions: Advanced Solid Tumors
Being tested: Recombinant human IL-21-expressing oncolytic vaccinia virus injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant human IL-21-expressing oncolytic vaccinia virus injectionBiological
Also called hV01
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.

Study groups in NCT05914376
Study group	Role	What they receive
hV01 intratumoral injection	Experimental	Single-dose phase (3+3 design): Participants will receive an intratumoral injection of hV01 at one of the dose levels from 1.0×10^7 PFU to 8.0×10^8 PFU on Day 1 of each treatment cycle. The MTD or MAD will be determined based on the safety and tolerability outcomes of this phase. Multiple-dose phase (3+3 design): 1. Two doses per cycle: Participants will receive two intratumoral injections of hV01 at the dose level of sub-MTD or sub-MAD on Day 1 and Day 8 of each treatment cycle. 2. Three doses per cycle: Participants will receive three intratumoral injections of hV01 at the dose level of sub-MTD or sub-MAD on Day 1, Day 8 and Day 15 of each treatment cycle. Receives: Biological: Recombinant human IL-21-expressing oncolytic vaccinia virus injection

What is being measured

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

To assess the Dose-limiting toxicities (DLTs) of hV01.
To identify dose-limiting toxicities (DLTs) of hV01 administered by single or multiple intratumoral injections.
Measured: From first dose till 28 days after last dose.
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 single or multiple intratumoral injections at different dose levels. 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.
Measured: From informed consent to approximately 3 months after End of Trial (EOT)

Secondary outcomes (8)

Pharmacokinetics of hV01.
To evaluate the hV01 DNA concentrations in peripheral blood at different time points.
Measured: From baseline to 28 days after last dose.
Expression of IL-21.
To evaluate IL-21 levels in peripheral blood at different time points.
Measured: From baseline to 28 days after last dose.
Viral shedding of hV01.
To evaluate hV01 DNA levels in urine and feces, and also quantities of hV01 DNA recovered from throat swab and injection site swab.
Measured: From baseline to 28 days after last dose.
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.
Measured: 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.
Measured: 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.
Measured: 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: progression-free survival (PFS).
To evaluate the progression-free survival (PFS) as a measurement of tumor response and disease progression.
Measured: 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.
Measured: From signing informed consent form until the date of death from any cause, assessed up to 2 years after the end of treatment.

Timeline

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

5 Jul 202310 Jun 2027

First posted22 Jun 2023
Study start5 Jul 2023
Primary completion2 Jul 2025
Study completion10 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05914376
Sponsor's protocol ID: hV01-ITu-101
Status last verified: Feb 2026
First submitted: 31 May 2023
Last updated: 27 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05914376
Acronym / sponsor ID: hV01-ITu-101
Conditions: Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Hangzhou Converd Co., Ltd.Industry (pharma, biotech, devices)
Study start: 5 Jul 2023 (actual)
Primary completion: 2 Jul 2025 (actual)
Study completion: 10 Jun 2027 (estimated)
First posted: 22 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
hV01 intratumoral injection	Experimental	Biological: Recombinant human IL-21-expressing oncolytic vaccinia virus injectionSingle-dose phase (3+3 design): Participants will receive an intratumoral injection of hV01 at one of the dose levels from 1.0×10^7 PFU to 8.0×10^8 PFU on Day 1 of each treatment cycle. The MTD or MAD will be determined based on the safety and tolerability outcomes of this phase. Multiple-dose phase (3+3 design): 1. Two doses per cycle: Participants will receive two intratumoral injections of hV01 at the dose level of sub-MTD or sub-MAD on Day 1 and Day 8 of each treatment cycle. 2. Three doses per cycle: Participants will receive three intratumoral injections of hV01 at the dose level of sub-MTD or sub-MAD on Day 1, Day 8 and Day 15 of each treatment cycle.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (19 listed)

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).
Previous allogeneic stem cell or organ transplantation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant human IL-21-expressing oncolytic vaccinia virus injectionAlso: hV01hV01 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.	Biological	hV01 intratumoral injection

Primary outcome

To assess the Dose-limiting toxicities (DLTs) of hV01.
Time frame: From first dose till 28 days after last dose.
To identify dose-limiting toxicities (DLTs) of hV01 administered by single or multiple intratumoral injections.
To assess the adverse events (AEs) and tolerability of hV01.
Time frame: From informed consent to approximately 3 months after End of Trial (EOT)
To assess the frequency, severity, and nature of adverse events (AEs) of hV01 administered by single or multiple intratumoral injections at different dose levels. 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.

8 secondary outcomes

Pharmacokinetics of hV01.
Time frame: From baseline to 28 days after last dose.
Expression of IL-21.
Time frame: From baseline to 28 days after last dose.
Viral shedding of hV01.
Time frame: From baseline to 28 days after last dose.
Anti-tumor activity of hV01: overall response rate (ORR).
Time frame: 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).
Time frame: 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).
Time frame: 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: progression-free survival (PFS).
Time frame: 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).
Time frame: From signing informed consent form until the date of death from any cause, assessed up to 2 years after the end of treatment.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Individual participant dataSharing planned: No

Related trials for Advanced Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jian Zhang principal investigator

Fudan University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant human IL-21-expressing oncolytic vaccinia virus injection in people with Advanced Solid Tumors, run by Hangzhou Converd Co., Ltd. at 2 sites 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 12 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the Dose-limiting toxicities (DLTs) of hV01. (time frame: From first dose till 28 days after last dose.). The study lists 2 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 NCT05914376.

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 27 Feb 2026.