Actively Recruiting
A Study to Evaluate Combination Therapy of Oncolytic Vaccinia Virus (hV01) and PD-1 Inhibitor in Advanced Solid Tumors.
Led by Hangzhou Converd Co., Ltd. · Updated on 2025-09-22
24
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
H
Hangzhou Converd Co., Ltd.
Lead Sponsor
X
Xiamen Humanity Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Combination Therapy of Oncolytic Vaccinia Virus (hV01) and PD-1 Inhibitor in Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed an informed consent form.
- Men or women aged 18 to 75 years.
- Histologically or cytologically confirmed advanced solid tumors unresponsive to standard therapies.
- At least one measurable tumor lesion suitable for intratumoral hV01 injection, with a longest diameter over 1.5 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of at least 6 months.
- Baseline lab values meeting specified hematology, liver, kidney, and coagulation criteria.
- Female patients of childbearing potential must have a negative serum pregnancy test or meet defined menopausal or sterilization criteria.
You will not qualify if you...
- Received systemic anti-tumor treatments within 4 weeks before first hV01 dose, with longer intervals for certain drugs.
- Received small-molecule targeted therapy within 2 weeks or five half-lives before first hV01 dose.
- Had radiotherapy (except palliative) within 2 weeks before first hV01 dose.
- Previous treatment with an oncolytic virus.
- Participated in other investigational drug trials within 4 weeks prior to first hV01 dose.
- Uncontrolled central nervous system or meningeal metastases.
- Known or suspected active autoimmune diseases.
- History of allogeneic stem cell or organ transplant.
- Severe cardiovascular or cerebrovascular diseases within 12 months before first hV01 dose.
- Severe arrhythmias requiring treatment.
- NYHA class II or higher heart failure or LVEF less than 50%.
- Uncontrolled hypertension or hypotension despite treatment.
- Significant pericardial or pleural effusions.
- Significant bleeding or bleeding tendency within 6 months before first hV01 dose.
- Severe inflammatory skin diseases requiring systemic treatment.
- Active infections requiring systemic therapy, including tuberculosis, sepsis, or viremia.
- Active HIV, syphilis, hepatitis B or C infections.
- Use of therapeutic corticosteroids above specified doses within 2 weeks before first hV01 dose.
- Use of live vaccines within 4 weeks before first hV01 dose.
- History of severe allergies.
- Mental disorders impacting study compliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xiamen Humanity Hospital
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
J
Jun Qiu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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