Phase IbII Study of 9MW2821 and Toripalimab for Advanced or Metastatic Urothelial Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, effectiveness, pharmacokinetics, and immune response of a combination treatment using 9MW2821 and Toripalimab injections in adults with locally advanced or metastatic urothelial cancer. This phase IbII open-label study is conducted at multiple centers to better understand this treatment approach for this advanced cancer type. Participants receive 9MW2821 at doses of 1.0, 1.25, or 1.5 mgkg by intravenous infusion every cycle, combined with 240 mg of Toripalimab given intravenously every cycle. Treatment continues until the disease progresses or side effects become intolerable. This single-arm trial does not include a comparison group and monitors patients closely during the treatment period. During the study, participants undergo regular assessments including safety monitoring for adverse events up to 24 months. Researchers also measure tumor response, progression-free survival, overall survival, and pharmacokinetics over 12 to 24 months. Participants must provide tumor tissue samples and complete study procedures, with ongoing monitoring of immunogenicity and disease control throughout the trial duration.

9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer