Jiangsu Yasheng Pharmaceutical Development Co. Ltd.

The main purpose of Phase Ib is to evaluate the safety and tolerability of APG-1387 combined with albumin-paclitaxel and gemcitabine in patients with advanced pancreatic cancer and to determine the MTD and RP2D of APG-1387 in combination therapy. The main purpose of Phase II is to evaluate the objective response rate (ORR) of APG-1387 combined with albumin-paclitaxel and gemcitabine in patients with relapsed, refractory and metastatic pancreatic cancer who have progressed after first-line standard treatment.

Phase I: Evaluate the maximum tolerated dose (MTD) of APG-1387 combined with entecavir tablets. Phase II: Determine the safety, tolerability, pharmacokinetic characteristics and preliminary anti-HBV efficacy of different doses of APG-1387 combined with entecavir tablets, and select the optimal clinical dosage of APG-1387 combined with entecavir tablets for the treatment of chronic hepatitis B.

The main purpose of the Phase Ib study is to evaluate the safety and tolerability of APG-1387 combined with toripalimab in the treatment of patients with advanced solid tumors, in order to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of APG-1387 for combined treatment. The main purpose of the Phase II study is to evaluate the anti-tumor activity (DCR) of APG-1387 combined with toripalimab in the treatment of patients with microsatellite stable advanced colorectal cancer, advanced nasopharyngeal carcinoma and advanced non-small cell lung cancer.