FDA018 Antibody Drug Conjugate(Shanghai Fudan Zhangjiang Bio Pharmaceutical)

In patients with locally advanced, recurrent or metastatic triple-negative breast cancer who have failed taxane therapy, the primary objective is to compare the efficacy of FDA018-ADC with investigator-selected chemotherapy (ICC). Secondary objectives are to compare the safety and tolerability of FDA018-ADC with ICC; to evaluate the immunogenicity of FDA018-ADC; and to evaluate the pharmacokinetic characteristics of FDA018-ADC. Exploratory objectives are to preliminarily evaluate the relationship between the expression level of Trop-2 in tumor tissue and the anti-tumor efficacy of FDA018-ADC.

Dose escalation study 1) Primary objectives: To evaluate the safety and tolerability of FDA018-ADC in patients with advanced solid tumors; To explore the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs). 2) Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of FDA018-ADC in patients with advanced solid tumors; To preliminarily evaluate the efficacy of FDA018-ADC in patients with advanced solid tumors; To preliminarily evaluate the immunogenicity of FDA018-ADC in patients with advanced solid tumors. Expanded enrollment study Primary objectives: To further evaluate the efficacy, safety and pharmacokinetic characteristics of FDA018-ADC in patients with advanced solid tumors; To determine the recommended dose (RP2D) for Phase II.