The clinical trial (CTR20232677) is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetic profile of 9MW2821 in combination with PD-1 inhibitor in patients with locally advanced or metastatic urothelial carcinoma.

9MW2821 is a novel Nectin-4 targeting ADC developed by world-class ADC development platform and automated high-throughput antibody discovery platform of Mabwell. It achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.

9MW2821 boasts the advantages of homogenous composition, higher purity and it is suitable for industrial scale-up. The preliminary data show positive therapeutic signals in solid tumors, and good safety profile at the recommended phase II dose (RP2D). Mabwell is promoting the enrollment of multiple cohorts of UC, CC, prostate cancer, HER-2 negative breast cancer, and non-small cell lung cancer. The R&D progress of 9MW2821 ranks first in China and second in the world. 9MW2821 is the first to receive preliminary clinical data in cervical cancer among the drug candidates with the same target in the world. Phased data will be published on ESMO Congress 2023.