Advanced Solid TumorsNCT07185243
A Study to Evaluate Combination Therapy of Oncolytic Vaccinia Virus (hV01) and PD-1 Inhibitor in Advanced Solid Tumors.
A study testing recombinant human IL-21-expressing oncolytic vaccinia virus injection in people with Advanced Solid Tumors, run by Hangzhou Converd Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and primary efficacy of the combination therapy of recombinant human IL-21-expressing oncolytic vaccinia virus (hV01) and the PD-1 Inhibitor Tislelizumab 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
- 1 siteChina
- Study dates
- 23 Jun 2025to Jun 2028
- Phase
- Interventional
- 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 solid tumors refractory or failed to respond to standard therapies.
- At least one measurable lesion according to RECIST v1.1 criteria, which is suitable for intratumoral injection of hV01 either directly or with the assistance of B-ultrasound, or CT scan. The baseline longest diameter of the lesion targeted for injection should be more than 1.5 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of at least 6 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; (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)]; (4) 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. Note: non-childbearing potential as defined by at least one of the following criteria: surgeries resulted in permanent sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or are post-menopausal; For females aged 50 or older, they will be considered menopausal if they are in amenorrhea, defined as the absence of menstruation for the previous 12 months before screening, which is not caused by any disease; For females younger than 50 years, they will be considered menopausal if they satisfy all the following requirements during screening: they are in amenorrhea, defined as the absence of menstruation for the previous 12 months after termination of hormone treatment, and they have a serum FSH level within the laboratory's reference range for postmenopausal females.
Who cannot join
- 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 of hV01 (within 6 weeks of dosing for nitrosourea or mitomycin C); (2) Small-molecule targeted therapy within 2 weeks before first dose of hV01 or within five half-lives of the small-molecule targeted drug (whichever is longer); (3)Radiotherapy (excluding palliative radiotherapy) within 2 weeks before first dose of hV01. (4) previous treatment with an oncolytic virus.
- Receiving any investigational drugs for clinical trials within 4 weeks prior to the first dose of hV01.
- 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).
- Patients who have received an allogeneic stem cell transplant or organ transplant.
- Patients with a history of severe cardiovascular and cerebrovascular diseases, including: (1) 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 first hV01 dosing; (2) Severe arrhythmia requiring clinical intervention; (3) New York Heart Association (NYHA) classification of class II or above, or left ventricular ejection fraction (LVEF) <50%; (4) Uncontrolled hypertension or hypotension despite standard treatment.
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- Clinically significant and/or rapidly accumulating pericardial and/or pleural effusion.
- Bleeding symptoms of great clinical significance or clear bleeding tendency within six months prior to the initial dose of hV01.
- Severe inflammatory skin diseases that require treatment with medicines (e.g., eczema or psoriasis requiring systematic 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).
- Receiving therapeutic dosages of corticosteroids such as prednisone or its equivalent >10 mg daily within two weeks prior to the first dose of hV01, or having any coexisting diseases that might require systemic corticosteroids or any other immune suppressors during the study (assessed by the investigators) with the following exceptions: local administration of glucocorticoid (e.g. topical routes such as for eyes, intra-articular, intranasal, or inhaled); or usage of glucocorticoids for a short period of time for preventive purposes such as for the prevention of contrast media hypersensitivity).
- Receiving any of the live vaccines within four weeks of the first dose of hV01.
- Patients with a history of severe allergies.
- Mental disorders that could potentially impact the participant's ability to comply with the study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiamen Humanity Hospital
Xiamen, Fujian, 361000
About this study
Official title: A Study Evaluating the Safety and Efficacy of hV01, a Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus, in Combination With the PD-1 Inhibitor Tislelizumab for Advanced Solid Tumors.
The purpose of this study is to evaluate the safety and primary efficacy of the combination therapy of recombinant human IL-21-expressing oncolytic vaccinia virus (hV01) and the PD-1 Inhibitor Tislelizumab in patients with advanced solid tumors.
Read the detailed description
This study is divided into two parts and follows a single-arm design.
Part A evaluates the safety and tolerability of hV01 administration at two different frequencies: twice per 28-day cycle (on days 1 and 3) and three times per 28-day cycle (on days 1, 3, and 5). The study will adhere to the 3+3 principle for monitoring dose-limiting toxicity (DLT).
Part B assesses the combination of hV01 and Tislelizumab. This phase will involve multiple administrations of hV01 (either twice or three times per 42-day cycle), followed by the administration of Tislelizumab on days 14 and 35. Monitoring for DLTs will also be conducted for the first 3 or 6 subjects in this phase.
Efficacy will be evaluated using the RECIST v1.1 criteria.
- 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 group | Role | What they receive |
|---|---|---|
| hV01 as a single agent, and combined with Tislelizumab | Experimental | Part A:
The first group of participants will receive an intratumoral injection of hV01 on days 1 and 3 of each 28-day cycle.
The second group of participants will receive an intratumoral injection of hV01 on days 1, 3, and 5 of each 28-day cycle.
Part B:
Based on the results from Part A, participants will receive an intratumoral injection of hV01 on days 1 and 3 or on days 1, 3, and 5, followed by intravenous infusion of Tislelizumab on days 14 and 35 of each 42-day 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.
Dose-limiting toxicities
To observe dose-limiting toxicities (DLTs) after hV01 administration as a single agent, or combined with Tislelizumab.
Measured: From the first hV01 dose till the end of cycle 1 (each cycle is 28 days in Part A and 42 days in Part B of the study).
Adverse events
Assess the frequency, severity, and nature of adverse events (AEs).
Measured: From informed consent to approximately 3 months after the End of Treatment (EOT).
Secondary outcomes (5)
Overall Response Rate (ORR)
The proportion of patients who have a partial or complete response to therapy.
Measured: Until the first documented disease progression or death from any cause, up to 2 years after EOT.
Disease Control Rate (DCR)
The percentage of participants who gain a complete response, a partial response, or stable disease.
Measured: Until the first documented disease progression or death from any cause, up to 2 years after EOT.
Duration of Response (DOR)
The time from administration of the first dose of hV01 to disease progression or death in patients who achieve a complete or partial response.
Measured: Until the first documented disease progression or death from any cause, up to 2 years after EOT.
Progression-Free Survival (PFS)
The time from administration of the first dose of hV01 to disease progression or death from any cause.
Measured: Until the first documented disease progression or death from any cause, up to 2 years after EOT.
Overall Survival (OS)
The length of time from administration of the first dose of hV01 during which patients are still alive.
Measured: Until the date of death from any cause, up to 2 years after EOT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start23 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Converd Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xiamen Humanity Hospital
- Responsible party
- Sponsor
- Investigators
- Cheng Huang, Principal investigator, Xiamen Humanity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185243
- Sponsor's protocol ID
- hV01-IST-02
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Safety and Efficacy of hV01, a Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus, in Combination With the PD-1 Inhibitor Tislelizumab for Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT07185243
- Acronym / sponsor ID
- hV01-IST-02
- Conditions
- Advanced Solid Tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hangzhou Converd Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xiamen Humanity Hospital
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Sep 2025 (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.
The purpose of this study is to evaluate the safety and primary efficacy of the combination therapy of recombinant human IL-21-expressing oncolytic vaccinia virus (hV01) and the PD-1 Inhibitor Tislelizumab in patients with advanced solid tumors.
Detailed description
This study is divided into two parts and follows a single-arm design.
Part A evaluates the safety and tolerability of hV01 administration at two different frequencies: twice per 28-day cycle (on days 1 and 3) and three times per 28-day cycle (on days 1, 3, and 5). The study will adhere to the 3+3 principle for monitoring dose-limiting toxicity (DLT).
Part B assesses the combination of hV01 and Tislelizumab. This phase will involve multiple administrations of hV01 (either twice or three times per 42-day cycle), followed by the administration of Tislelizumab on days 14 and 35. Monitoring for DLTs will also be conducted for the first 3 or 6 subjects in this phase.
Efficacy will be evaluated using the RECIST v1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hV01 as a single agent, and combined with Tislelizumab | Experimental | Biological: recombinant human IL-21-expressing oncolytic vaccinia virus injectionPart A: The first group of participants will receive an intratumoral injection of hV01 on days 1 and 3 of each 28-day cycle. The second group of participants will receive an intratumoral injection of hV01 on days 1, 3, and 5 of each 28-day cycle. Part B: Based on the results from Part A, participants will receive an intratumoral injection of hV01 on days 1 and 3 or on days 1, 3, and 5, followed by intravenous infusion of Tislelizumab on days 14 and 35 of each 42-day cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signing an informed consent form.
- Men or women aged 18 to 75 years.
- Histologically and/or cytologically confirmed advanced solid tumors refractory or failed to respond to standard therapies.
- At least one measurable lesion according to RECIST v1.1 criteria, which is suitable for intratumoral injection of hV01 either directly or with the assistance of B-ultrasound, or CT scan. The baseline longest diameter of the lesion targeted for injection should be more than 1.5 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Key exclusion criteria (15 listed)
- 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 of hV01 (within 6 weeks of dosing for nitrosourea or mitomycin C); (2) Small-molecule targeted therapy within 2 weeks before first dose of hV01 or within five half-lives of the small-molecule targeted drug (whichever is longer); (3)Radiotherapy (excluding palliative radiotherapy) within 2 weeks before first dose of hV01. (4) previous treatment with an oncolytic virus.
- Receiving any investigational drugs for clinical trials within 4 weeks prior to the first dose of hV01.
- 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).
- Patients who have received an allogeneic stem cell transplant or organ transplant.
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 as a single agent, and combined with Tislelizumab |
Primary outcome
Dose-limiting toxicities
Time frame: From the first hV01 dose till the end of cycle 1 (each cycle is 28 days in Part A and 42 days in Part B of the study).
To observe dose-limiting toxicities (DLTs) after hV01 administration as a single agent, or combined with Tislelizumab.
Adverse events
Time frame: From informed consent to approximately 3 months after the End of Treatment (EOT).
Assess the frequency, severity, and nature of adverse events (AEs).
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: Until the first documented disease progression or death from any cause, up to 2 years after EOT.
Disease Control Rate (DCR)
Time frame: Until the first documented disease progression or death from any cause, up to 2 years after EOT.
Duration of Response (DOR)
Time frame: Until the first documented disease progression or death from any cause, up to 2 years after EOT.
Progression-Free Survival (PFS)
Time frame: Until the first documented disease progression or death from any cause, up to 2 years after EOT.
Overall Survival (OS)
Time frame: Until the date of death from any cause, up to 2 years after EOT.
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 22 Sep 2025.
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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.
Cheng Huang principal investigator
Xiamen Humanity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recombinant human IL-21-expressing oncolytic vaccinia virus injection in people with Advanced Solid Tumors, run by Hangzhou Converd Co., 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 8 inclusion and 15 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 22 Sep 2025. 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.
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 Jun Qiu (+86 13696902986, 290791225@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (time frame: From the first hV01 dose till the end of cycle 1 (each cycle is 28 days in Part A and 42 days in Part B of the study).). 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?
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 22 Sep 2025.