Multicenter phase 1-2 study of the next-generation nectin-4 targeting antibody-drug conjugate 9MW2821 for advanced solid tumors

A multicenter first-in-human phase 1-2 study in China evaluated the next-generation antibody-durg conjugate 9MM2821 (delevering monomethylauristatine E to cells expressing nectin-4) in patients with advanced solid tumors who failed ≥ 1 line of systemic therapy. The recommended phase 2 dose was 1.25 mg/kg on days 1, 8, and 15 of 28-day cycles. This dose was tolerated with grade ≥ 3 treatment-related adverse events neutrophil and white blood cells decrease, anemia, gamma-glutamyl transferase increase, rash, and peripheral sensory neuropathy. Objective response rates were 54%, 32%, 14%, and 50% in urothelial cancer, cervical cancer, esophageal cancer, and triple negative breast cancer, respectively. The authors conclude that 9MW2821 was tolerated and had clinically relevant activity for advanced urothelial cancer and several other types of solid tumors.