Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 1349) and the Shanghai Stock Exchange (SHA: 688505), has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate FDA018. This TROP2 antibody-drug conjugate (ADC) is under development for the treatment of advanced solid tumors, with a focus on triple-negative breast cancer (TNBC).
The Phase I clinical study demonstrated that FDA018 has shown good tolerability and manageable safety profiles, with the maximum tolerated dose (MTD) not yet reached at a dosage of 12.0mg/kg. In the cohort of 29 TNBC patients treated with a dosage of 10.0mg/kg, the objective response rate (ORR) and disease control rate (DCR) were recorded at 37.9% and 79.3%, respectively. These results indicate promising early anti-tumor activity for the drug candidate.- Flcube.com
