A Single-arm, Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred.
• Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.
• Age 18 to 75 years old (inclusive), gender is not limited.
• Patients with advanced bone and soft tissue sarcoma confirmed by histopathological or cytology, who are unresectable by surgery and have failed at least one standard treatment (among them, patients with Ewing sarcoma need to be patients without standard treatment).
• According to RECIST 1.1, it is determined that at least one CT examination shows measurable and meets the volume requirement for the first injection, superficial lesions are preferred, and tumor lesions that can be injected under ultrasound guidance can also be selected (the injected lesions are preferably major tumor burden lesions), and the longest diameter of the injected lesion at baseline (short diameter for lymph node lesions) \> 1.5cm.
• Those who have a positive HSV-1 IgG or HSV-1 IgM antibody test result (HSV-1 IgM).
• ECOG physical status score of 0-1.
• Estimated survival time of more than 3 months.
• Have adequate organ function:
‣ Blood routine (no blood transfusion or colony-stimulating factor therapy within 14 days): ANC≥1.5×109/L, PLT≥75×109/L, Hb≥85g/L, lymphocyte count≥1.5×109/L (for lymphocyte count 0.8×109/L to 1.5×109/L at the discretion of the investigator);
⁃ Liver function: TBIL ≤1.5×ULN, ALT≤3×ULN, AST≤3×ULN (ALT≤5×ULN and AST≤5×ULN are acceptable for patients with liver metastases);
⁃ Renal function: Cr≤1.5×ULN, and creatinine clearance ≥45ml/min (calculated according to Cockcroft-Gault formula);
⁃ Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR) ≤1.5×ULN.
• Eligible subjects (males and females) of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) for the duration of the trial and for at least 3 months after the last dose; Female patients of childbearing potential must have a negative blood pregnancy test within 7 days prior to enrollment.