Hefei Hankemaibo Biotechnology Co., Ltd.

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.

To evaluate the safety and tolerability of HuA21 in the treatment of patients with HER2-positive advanced malignant solid tumors, and to explore the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD); Preliminary observation of the anti-tumor efficacy of HuA21 combined with trastuzumab and chemotherapy drugs in the treatment of patients with HER2-positive various specific advanced malignant solid tumors.