Xinghande Biomedical (Shanghai) Co., Ltd.

The primary study objective is to evaluate the safety and tolerability of SCG142 in the treatment of HPV16 or HPV52-related malignancies. The secondary study objective is to evaluate the preliminary clinical efficacy of SCG142 in the treatment of HPV16 or HPV52-related malignancies and the pharmacokinetic characteristics of SCG142 before and after intravenous infusion.

Main study objectives To evaluate the safety, tolerability and dose-limiting toxicity (DLT) of SCG101 in the treatment of hepatitis B virus-related hepatocellular carcinoma (HBV-HCC), and to determine the maximum tolerated dose (MTD) or phase II recommended dose (RP2D). Secondary study objectives To evaluate the preliminary clinical efficacy of SCG101 in the treatment of HBV-HCC; To evaluate the antiviral activity of SCG101, as well as its effects on liver function and serum tumor marker alpha-fetoprotein (AFP) levels; To evaluate the changes in pharmacokinetic characteristics (viral vector copy number (VCN)) of SCG101 before and after intravenous infusion. Exploratory objectives To evaluate the changes in peripheral blood SCG101 concentrations before and after intravenous infusion of SCG101; To evaluate the changes in related cytokines before and after intravenous infusion of SCG101; To evaluate the changes in immune characteristics before and after intravenous infusion of SCG101.