Zhongsheng Shangjian Biomedical (Hangzhou) Co., Ltd.

Phase Ia study objectives: Main objectives: 1) Safety and tolerability; 2) Exploration of MTD or MAD; 3) Preliminary determination of Phase II recommended dose (RP2D). Secondary objectives: 1) Evaluate the PK characteristics of SG1906 in patients with CLDN18.2-positive locally advanced unresectable or metastatic solid tumors; 2) Evaluate PD characteristics; 3) Evaluate the immunogenicity of SG1906; 4) Preliminary evaluation of the anti-tumor efficacy of SG1906 monotherapy. Phase Ib study objectives: Main objectives: 1) Determine the RP2D of SG1906 in patients with CLDN18.2-positive locally advanced unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma and pancreatic cancer (PC); 2) Safety and tolerability; 3) Evaluate the tumor response of SG1906 in patients with CLDN18.2-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma and PC. Secondary objectives: 1) Evaluate the anti-tumor efficacy of SG1906 in patients with CLDN18.2-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma and PC; 2) Evaluate the pharmacokinetic PK characteristics; 3) Evaluate the PD characteristics; 4) Evaluate the immunogenicity of SG1906. Exploratory objectives To explore potential biomarkers in tumor tissue/blood that predict the efficacy of SG1906 (including but not limited to CLDN18.2 expression).

The main objectives of Phase Ia: 1) Safety and tolerability; 2) Exploration of MTD or MAD. Secondary objectives: 1) Evaluate the PK characteristics of SG1408 in patients with advanced malignant solid tumors; 2) Evaluate the PD characteristics of SG1408 in patients with advanced malignant solid tumors; 3) Evaluate the immunogenicity of SG1408; 4) Evaluate the preliminary anti-tumor efficacy of SG1408 monotherapy. Exploratory objectives: 1) Explore potential biomarkers of SG1408 in tumor tissue/blood. The main objectives of Phase Ib: 1) Safety and tolerability; 2) Determine RP2D; 3) Preliminary anti-tumor efficacy. . Secondary objectives: 1) Further evaluate the PK characteristics of SG1408 in patients with advanced malignant solid tumors; 2) Further evaluate the PD characteristics of SG1408 in patients with advanced malignant solid tumors; 3) Further evaluate the immunogenicity of SG1408 in patients with advanced malignant solid tumors. Exploratory objectives: 1) Explore potential biomarkers of SG1408 in tumor tissue/blood.

Primary objectives: 1) To evaluate the safety and tolerability of SG404 for injection in patients with advanced malignant tumors. 2) To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of intravenous SG404 for injection in patients with advanced malignant tumors, and to provide a basis for the dosing regimen and dosage of Phase II clinical trials. Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of SG404 for injection in patients with advanced malignant tumors. 2) To evaluate the pharmacodynamic characteristics of SG404 for injection in patients with advanced malignant tumors. 3) To evaluate the immunogenicity of SG404 for injection in patients with advanced malignant tumors. 4) To preliminarily evaluate the efficacy of SG404 for injection in patients with advanced malignant tumors. Exploratory objectives: To explore biomarkers in tumor tissues that may potentially predict the efficacy of SG404 for injection.