A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of the Virus, Pharmacodynamics, Immunogenicity, and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patient With Advanced Solid Tumors.
The present trial is an open, single-arm phase I clinical study aimed at assessing the safety, tolerability, viral distribution and shedding patterns, pharmacodynamics, immunogenicity, and antitumor efficacy of GC001 oncolytic virus injection in patients with advanced solid tumors following a single administration.
∙ To be eligible for participation in this study, individuals must meet the following criteria:
• Fully comprehend the purpose, nature, methods, and potential adverse effects of the trial, volunteer as a participant, and provide informed consent by signing the form prior to undergoing any procedures.
• Be male or female patients aged 18 to 75 years (including those with borderline age values).
• Patients with advanced solid tumors, including but not limited to: colorectal cancer, lung cancer, ovarian cancer, cervical cancer, etc., that have been histologically or cytologically diagnosed and for which there is either no current standard of care or the standard treatment has proven ineffective (progression of the disease after treatment or intolerance of treatment).
• Possess at least one extracranial measurable lesion (as determined by a CT scan or MRI conducted no more than 4 weeks before signing the informed consent form) that is suitable for intratumoral injection based on RECIST v1.1 criteria.
• Have an Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1.
• Be expected to survive for at least 3 months.
• Within 7 days prior to receiving the first dose of treatment, patients must meet the following organ function and bone marrow reserve:
‣ Hematology: platelets (PLT) ≥ 80 × 109/L, neutrophil count (ANC) ≥ 1.5 × 109/L, and hemoglobin ≥ 9 g/dL (without having received adjuvants like EPO, G-CSF, or GM-CSF in the 14 days leading up to the first dose, and not having received a blood transfusion for at least 7 days);
⁃ Coagulation function: INR ≤ 1.2, APTT ≤ 1.2 × ULN (upper limit of normal), PT ≤ 1.2 × ULN;
⁃ Hepatic function: total bilirubin ≤ 1.5
⁃ × ULN (patients with Gilbert syndrome may be enrolled with a total bilirubin ≤ 3 × ULN), AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN in the presence of hepatic metastases);
⁃ Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (according to the Cockcroft-Gault formula, see Appendix 2 for details);
⁃ Cardiac function: QT interval (QTcF) ≤ 470 ms in female and ≤ 450 ms in male.
• Ability to effectively communicate with the investigator and comprehend and adhere to the requirements of the study.