Phase II Study of 9MW2821 and Toripalimab Infusions for Perioperative Treatment of Urothelial Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining the drugs 9MW2821 and Toripalimab in patients with urothelial cancer who are undergoing surgery. This phase II clinical trial is open-label and involves multiple centers. The study focuses on patients with confirmed non-metastatic urothelial cancer, including muscle-invasive bladder cancer MIBC and high-risk upper tract urothelial carcinoma UTUC. Participants receive intravenous infusions of 9MW2821 at a dose of 1.25 mgkg and Toripalimab at 240 mg. The study includes three groups based on cancer type and risk Arm 1 with MIBC, Arm 2 with high-risk UTUC, and Arm 3 with MIBC. The study is not randomized, and all participants receive the experimental treatment combination. During the study, participants will be monitored for up to 24 months to assess outcomes such as pathological complete response pCR, clinical complete response cCR, overall response rate, disease-free survival, progression-free survival, overall survival, and safety events. Researchers will also evaluate immunogenicity and expression of biomarkers Nectin-4 and PD-L1. Regular assessments include tumor tissue testing and organ function monitoring to ensure participant safety and treatment adherence.

9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer