SYS6043

Abnormal expression of B7-H3 is closely related to the occurrence and progression of cancer. SYS6043 is an ADC product targeting B7-H3. The preclinical pharmacological mechanism is clear, and pharmacodynamic tests show that SYS6043 has a significant tumor inhibitory effect and can significantly inhibit tumor growth in various preclinical in vivo models. This study is a multicenter, open-label, dose-escalation, PK amplification and cohort expansion first-in-human Phase I study designed to evaluate SYS6043 (B7-H3-targeted antibody drug conjugate) in patients with advanced/metastatic solid tumors The safety, tolerability, PK characteristics and preliminary anti-tumor efficacy include dose escalation, PK expansion and cohort expansion. The primary purpose of phase Ia dose escalation is to evaluate the maximum tolerated dose/maximum administered dose and the recommended dose for phase 2 clinical trials (RP2D). Phase Ia PK expansion uses 2-4 dose levels to further evaluate the safety, tolerability, PK characteristics and preliminary anti-tumor activity of SYS6043. The Phase Ib cohort expansion (Part 3) enrolls patients with advanced/metastatic solid tumors for selected indications and further evaluates safety and efficacy using selected RP2D doses.