Hefei Hankemaibo Biotechnology Co., Ltd.

Primary Objectives: To evaluate the safety and tolerability of HK010 injection in patients with advanced solid tumors expressing PD-L1 CPS≥1; To evaluate the efficacy of HK010 injection in patients with advanced solid tumors expressing PD-L1 CPS≥1, and to explore the dosage in a Phase III clinical trial. Secondary Objectives: To evaluate the pharmacokinetic (PK) and immunogenicity characteristics of HK010 injection in patients with advanced solid tumors expressing PD-L1 CPS≥1. Exploratory Objectives: (1) To explore the relationship between the expression of ① lymphocyte subsets and ② biomarkers related to immune regulation and cytokine release in the blood and the PK characteristics and efficacy of HK010 injection; (2) To explore the relationship between PD-L1 expression in tumor tissue and the efficacy of HK010 injection.

To evaluate the safety and tolerability of HuA21 injection combined with trastuzumab and chemotherapy in the treatment of patients with HER2-positive locally advanced/metastatic gastric cancer; to preliminarily evaluate the effectiveness of HuA21 injection combined with trastuzumab and chemotherapy in the treatment of patients with HER2-positive locally advanced/metastatic gastric cancer, and to provide a basis for the design of Phase III clinical trials and the determination of dosing regimens

Primary objective: To evaluate the safety and tolerability of HK010 injection in patients with advanced malignant tumors. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics, anti-tumor efficacy, and immunogenicity characteristics of HK010 injection in patients with advanced malignant tumors. Exploratory objective: To explore 1) the relationship between the expression of ① lymphocyte subsets, ② immune regulation and cytokine release-related biomarkers in the blood and the PK characteristics and efficacy of HK010 injection; 2) the relationship between the expression of PD-L1 in tumor tissue and the efficacy of HK010 injection.