Lijin Biomedical Technology Shanghai Co. Ltd.

Primary objective: To evaluate the safety and tolerability of two pre-set dose levels based on the evaluation data of treatment-related adverse events, and to determine the treatment dose of LVGN6051 combined with toripalimab and paclitaxel in Part 2 through the "safety run-in period" dose. The anti-tumor activity of LVGN6051 combined with toripalimab and paclitaxel was evaluated by independent center according to RECIST1.1: ORR. Secondary objective: The anti-tumor activity of LVGN6051 combined with toripalimab and paclitaxel was evaluated by the investigator according to RECIST1.1: ORR. The preliminary efficacy of the three-drug combination was evaluated by the investigator and ICR according to RECIST1.1: DoR, DCR, mPFS and mOS. The safety of LVGN6051 combined with toripalimab and paclitaxel was evaluated according to the incidence and severity of AEs and SAEs graded by CTCAE5.0. Exploratory objective: The efficacy was evaluated by the investigator according to iRECIST: ORR, DoR, DCR and mPFS. Evaluate the PK characteristics of single and multiple administrations of triple-drug combination therapy. Evaluate the correlation between PD-L1 expression and efficacy before triple-drug combination therapy, and the correlation between the characteristics of tumor tissue infiltrating immune cells and efficacy before and after triple-drug combination therapy. Evaluate the immunogenicity of triple-drug combination therapy: ADA.

Primary purpose: Phase Ib confirms safety, Phase II recommended combination dose (RP2D), and Phase II combination objective response rate (ORR) efficacy. Secondary purpose: Evaluate the safety of combination therapy, other efficacy other than ORR, immunogenicity, and pharmacokinetic (PK) characteristics of LVGN6051. Exploratory purpose: Evaluate tumor tissue biomarkers after LVGN6051 combined with anlotinib treatment to explore the correlation between biomarkers and anti-tumor efficacy. Evaluate the changes in biomarkers after LVGN6051 combined with anlotinib treatment.