A Phase 1 interventional study of Recombinant human IL-21-expressing oncolytic vaccinia virus injection in Advanced Solid Tumors, sponsored by Hangzhou Converd Co., Ltd.. Active, not recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Hangzhou Converd Co., Ltd. · Phase 1, Interventional, and Treatment
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.
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.
Hangzhou Converd Co., Ltd. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Required baseline laboratory data include:
Exclusion Criteria:
Receiving any of the following anti-tumor treatments within a specified time period:
History of severe cardiovascular and cerebrovascular diseases, including:
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.
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.
Also known as: hV01
To assess the Dose-limiting toxicities (DLTs) of hV01.
To identify dose-limiting toxicities (DLTs) of hV01 administered by single or multiple intratumoral injections.
Time frame: 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.
Time frame: From informed consent to approximately 3 months after End of Trial (EOT)
Pharmacokinetics of hV01.
To evaluate the hV01 DNA concentrations in peripheral blood at different time points.
Time frame: From baseline to 28 days after last dose.
Expression of IL-21.
To evaluate IL-21 levels in peripheral blood at different time points.
Time frame: 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.
Time frame: 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.
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).
To evaluate the disease control rate (DCR) as a measurement of tumor response and disease progression.
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).
To evaluate the duration of response (DOR) as a measurement of tumor response and disease progression.
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).
To evaluate the progression-free survival (PFS) as a measurement of tumor response and disease progression.
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).
To evaluate the overall survival (OS) as a measurement of preliminary efficacy.
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.
To evaluate the immunogenicity of hV01.
To assess the levels of anti-drug antibody (ADA) and neutralizing antibody (Nab) in the peripheral blood.
Time frame: From baseline to 4 weeks after the End of Treatment.
To assess immune cells in the peripheral blood
To assess the levels of lymphocytes (CD3+ cells, CD3+CD4+ cells, CD3+CD8+ cells, CD3+CD4+/CD3+CD8+, CD3-CD16+CD56+ cells, CD3-CD19+ cells) in the peripheral blood.
Time frame: From baseline to 4 weeks after the End of Treatment.
To assess cytokine levels in the peripheral blood.
To assess the levels of cytokines including IFN-γ, TNF-α, and IL-6 in the peripheral blood.
Time frame: From baseline to 4 weeks after the End of Treatment.
To assess the correlation between anti-tumor responses and expressions of tumor biomarkers
To assess the impact of baseline Epidermal Growth Factor Receptor (EGFR) or Vascular Endothelial Growth Factor Receptor (VEGFR) mutation on tumor response after hV01 treatment.
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.
Plan to share: No
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This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Hangzhou Converd Co., Ltd.