Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd)

This study is a one-arm, open, multicenter phase 1b/2 clinical trial of PE0116combined with PE0105 in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.PE0105 is administered as a fixed-dose intravenous injection(3mg/kg Q3w）.

主要目的 1）评估PE0105单药治疗的安全性和耐受性； 2）确定PE0105单药治疗的最大耐受剂量（MTD）或最大给药剂量（MAD），以及II期试验推荐剂量（RP2D) 次要目的 1）分析PE0105在晚期实体肿瘤患者中单次给药的PK特性； 2）分析抗PE0105抗体（ADA）的产生情况； 3）按照RECIST1.1标准，初步评估PE0105在晚期实体肿瘤患者中的抗肿瘤活性。