Suzhou Fuente Pharmaceutical Co., Ltd.

The primary objective of the Phase Ia dose escalation phase is to evaluate the safety and tolerability of SON-DP in subjects with advanced or recurrent solid tumors who have failed or are intolerant to standard therapy. Secondary objectives: 1) To evaluate the preliminary efficacy of SON-DP in subjects with advanced solid tumors who have failed or are intolerant to standard therapy. 2) Pharmacokinetic (PK) characteristics of the three SON-DP proteins. 3) To investigate the pharmacodynamic (PD) characteristics of SON-DP by evaluating changes in tumor cell/tissue morphology. 4) To evaluate the immunogenicity of SON-DP. The primary objective of the Phase Ib dose expansion phase is to evaluate the safety and tolerability of SON-DP in subjects with advanced or recurrent liver cancer (Group 1) and gastric cancer (Group 2) who have failed or are intolerant to standard therapy using the RP2D treatment dose. Secondary objectives: 1) To evaluate the clinical anti-tumor activity of SON-DP, administered intravenously (IV) once or twice a week for 4 weeks, with each 28-day cycle, until complete remission or disease progression, completion of protocol-specified treatment cycles, intolerance, or subject withdrawal, whichever occurs first. 2) To elucidate the pharmacodynamic (PD) characteristics of SON-DP by evaluating tumor cell morphological changes in subjects with advanced liver cancer and gastric cancer. 3) To further explore the in vivo concentrations of the 3 proteins of SON-DP. 4) To evaluate the immunogenicity of the 3 proteins of SON-DP.