YSCH-01 Via Nebulization in Pulmonary Metastasis of Advanced Solid Tumors and Non-small Cell Lung Cancer (NSCLC)

In dose escalation phase, subjects with pulmonary metastasis of advanced solid tumors and advanced non-small cell lung cancer will be enrolled to receive YSCH-01 treatment by inhalation via nebulization. The "3+3" design will be adopted to explore the MTD and determine RP2D. Two dose groups will be established as follows: Dose group 1: 2E+11 VP; Dose group 2: 4E+11 VP. All the subjects received a single dose of YSCH-01 treatment, followed by a 21-day DLT observation period. If no DLT occurred, the YSCH-01 will administered once a week thereafter until the investigator deemed that the subjects no longer benefited significantly, experienced intolerable toxicity, withdrew their informed consent, had disease progression, died, were lost to follow-up, or the investigator deemed that terminating the treatment was in the best interest of the subjects (whichever occurred first). In cohort expansion phase, subjects will receive the optimal dose and administration schedule determined during the dose escalation phase. The cohort expansion phase further evaluated the safety and preliminary efficacy of YSCH-01 and planned to include 3 cohorts, with 10-30 subjects in each cohort.