Lijin Biomedical Technology (Suzhou) Co., Ltd.

Primary objective: To evaluate the safety, tolerability, MTD, and/or RDE and/or RP2D of LVGN7409 monotherapy in adult subjects with locally advanced, metastatic or relapsed refractory malignancies. Secondary objectives: To evaluate the pharmacokinetics (PK) of LVGN7409 monotherapy after single and multiple administrations. To evaluate the preliminary anti-tumor activity of LVGN7409 monotherapy. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and the Response Evaluation Criteria for Immunotherapy in Solid Tumors (iRECIST), the preliminary anti-tumor activity was described by objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and progression-free survival (PFS). To evaluate the immunogenicity of LVGN7409 monotherapy. Exploratory objectives: To evaluate the changes in immune status with LVGN7409 monotherapy. To evaluate the changes in pharmacodynamic biomarkers with LVGN7409 monotherapy.

Main study objectives: 1) To evaluate the safety, tolerability, MTD and/or RDE and RP2D of LVGN6051 monotherapy in adult subjects with locally advanced or metastatic malignancies. 2) To evaluate the preliminary anti-tumor activity of LVGN6051 monotherapy. According to RECIST version 1.1, iRECIST or modified Cheson/Lugano criteria for lymphoma, ORR, DOR, DCR and PFS were used to describe the preliminary anti-tumor activity. 3) To evaluate the PK and ADA of LVGN6051 monotherapy. Exploratory objectives: 1) To evaluate the biomarker status of tumor tissues treated with LVGN6051 monotherapy to explore the correlation between relevant markers and anti-tumor efficacy. 2) To evaluate the changes in pharmacodynamic biomarkers of LVGN6051 monotherapy.