Safety of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advance… (NCT05914376) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Tumors
China24 participantsStarted 2023-07-05
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
To assess the Dose-limiting toxicities (DLTs) of hV01.
Timeframe: From first dose till 28 days after last dose.
2
To assess the adverse events (AEs) and tolerability of hV01.
Timeframe: From informed consent to approximately 3 months after End of Trial (EOT)
✕. 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%;