An Open-label, Randomized Phase 3 Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Urothelial Cancer Previously Treated with PD-(L)1 Inhibitor and Platinum-containing Chemotherapy

What this Trial Is About

Researchers are evaluating the antitumor activity of a drug called 9MW2821 compared to chemotherapy in adults with locally advanced or metastatic urothelial cancer. Participants have previously been treated with PD-(L)1 inhibitors and platinum-containing chemotherapy. This Phase 3 trial aims to understand how these treatments perform in this patient group to help guide future care decisions. Participants are randomly assigned to receive either 9MW2821 or chemotherapy chosen by their investigator. The 9MW2821 group receives 1.25 mg/kg of the drug through intravenous infusion on days 1, 8, and 15 of each 28-day cycle. The chemotherapy group receives either 75 mg/m² docetaxel or 175 mg/m² paclitaxel by intravenous infusion on day 1 of every 21-day cycle. Treatment continues with regular cycles until disease progression or other criteria are met. Throughout the study, participants undergo assessments for disease progression and survival up to three years. Researchers will review tumor response, duration and timing of response, disease control, quality of life, and monitor side effects and immune responses. Evaluations include imaging, laboratory tests, and quality-of-life questionnaires. Safety and overall health will be monitored regularly during treatment and follow-up periods.

A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer