Clinical Study of YH02 Injection for Intra-tumor Injection Therapy in Advanced Solid Tumors With Unresponsive or Failure-Treated Cases
The preclinical pharmacological mechanism of YH02 injection is well established. By constructing a vector expressing MMP13, introducing a human S promoter, and genetically modifying the capsid protein, the virus's permeability, tumor targeting capability, and infection efficiency were significantly enhanced. Preclinical pharmacodynamic studies demonstrated that YH02 exhibits potent tumor growth inhibitory effects in various human-and murine-derived solid tumor models (including breast cancer, liver cancer, and melanoma). Given that oncolytic virus therapies already have approved products with demonstrated safety and efficacy worldwide, this study may offer potential clinical benefits for patients with advanced solid tumors who have failed standard treatments. YH02 injection has undergone an open-label, dose-escalating, and expanded Phase I clinical study in China aimed at evaluating the safety, tolerability, biodistribution characteristics, viral clearance, and immunogenicity of intratumoral administration of YH02 injection in patients with advanced solid tumors who have failed adequate standard therapy and lack effective treatment options, while preliminarily investigating its efficacy. No high-grade adverse drug reactions (ADRs) have been observed to date, nor were there any serious adverse events (SAEs), severe adverse drug reactions (SUSARs), or fatal events. The clinical safety and tolerability of this product for intratumoral administration are favorable.
• Age: ≥18 years.
• Resectable malignant solid tumors confirmed by histology or cytology (including head and neck cancer, breast cancer, melanoma, cervical cancer, skin malignancies, salivary gland carcinoma, oropharyngeal carcinoma, etc.) should prioritize treatment options for head and neck cancer, breast cancer, and melanoma.
• After complete failure of standard treatment (disease progression or intolerance to therapy) and in the absence of effective therapeutic options.
• There must be at least one measurable lesion (according to the RECIST 1.1 criteria), and the lesion must be suitable for intratumoral injection.
• ECOG score ≤2.
• The expected survival period is ≥12 weeks.
• The subject must demonstrate adequate hematological and organ function, with all laboratory parameters evaluated within 7 days prior to the initial administration and meeting the following criteria: Hematologic system (no recent transfusion or hematopoietic stimulation therapy within 14 days): ANC ≥ 1.5 × 10⁹/L; PLT ≥ 80 × 10⁹/L; Hemoglobin (Hb) ≥ 85 g/L; Liver function: Total bilirubin (TBIL) ≤ 2 × upper limit of normal (ULN) (≤ 3.0 × ULN for patients with Gilbert syndrome or liver metastases/hepatocellular carcinoma); Alanine aminotransferase (ALT) ≤ 2.5 × ULN; For patients with liver metastases or hepatocellular carcinoma: ALT ≤ 5 × ULN; Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Albumin ≥ 2.8 g/dL; Renal function: Creatinine ≤ 1.5 × ULN; or Creatinine clearance (Ccr) ≥ 30 mL/min (calculated using the Cockcroft-Gault formula, only when creatinine\> 1.5 × ULN); Coagulation function: Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) or Prothrombin time (PT) ≤ 1.5 × ULN.
• The subject has voluntarily signed an informed consent form and demonstrates good compliance.