Beijing Yinmei Future Biomedical Technology Co., Ltd.

Primary objective: To compare the effectiveness of different dosing regimens of YH01 injection intravesical instillation in the treatment of patients with medium- and high-risk NMIBC who have failed or failed BCG instillation. Secondary objective: To evaluate the safety of different dosing regimens of YH01 injection intravesical instillation in the treatment of patients with medium- and high-risk NMIBC who have failed or failed BCG instillation. To evaluate the biodistribution characteristics, viral shedding and immunogenicity of different dosing regimens of YH01 injection intravesical instillation in the treatment of patients with medium- and high-risk NMIBC who have failed or failed BCG instillation. Exploratory objective: To evaluate the pharmacodynamic characteristics of different dosing regimens of YH01 injection intravesical instillation in the treatment of patients with medium- and high-risk NMIBC who have failed or failed BCG instillation (Phase IIa only). To evaluate the potential efficacy predictive biomarkers in tumor tissues of different dosing regimens of YH01 injection intravesical instillation in the treatment of patients with medium- and high-risk NMIBC who have failed or failed BCG instillation (Phase IIa only).

Phase I (dose escalation phase) Primary endpoint: Safety: To evaluate the safety and tolerability of YH01 injection after administration. Secondary endpoints: Biodistribution characteristics and viral shedding, immunogenicity, efficacy evaluated by RECIST v1.1: Exploratory endpoint: Pharmacodynamic evaluation Phase II (dose expansion phase) Primary objective: Investigators evaluate the objective response rate (ORR) of YH01 injection at the recommended dose in patients with advanced solid tumors who are ineffective or failed with standard treatment according to RECIST v1.1. Secondary objectives: Other efficacy indicators, safety, immunogenicity evaluated by researchers according to RECIST v1.1. Exploratory objectives: Pharmacodynamic characteristics, biomarkers.