Phase II Study Comparing 9MW2821 with and without Toripalimab for First-Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness of combining 9MW2821 with toripalimab compared to using 9MW2821 alone in patients with locally advanced or metastatic urothelial carcinoma who have not yet received systemic treatment for their advanced cancer. This randomized phase II trial aims to improve first-line treatment options for this condition, which includes urothelial carcinoma of the bladder, renal pelvis, and ureter. Participants will be assigned to receive either the combination of 9MW2821, a nectin-4 antibody-drug conjugate with MMAE payload, plus toripalimab, an anti-PD-1 antibody, or 9MW2821 monotherapy. The study treatments will be given according to protocol, with no masking or blinding. The trial includes a planned 3-year period to assess treatment response and safety. Throughout the study, participants will undergo regular assessments including evaluations of tumor response using RECIST v1.1 criteria, safety monitoring, and immunogenicity tests over three years. Researchers will measure outcomes such as the objective response rate and other efficacy endpoints. Participants must be able to follow study visits, treatment, and laboratory procedures, with contraceptive measures maintained until 180 days after the last dose. The overall participation spans from screening through treatment and follow-up over the study duration.

9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma