Phase 3 Study Comparing SHR-A2102 Injection to Investigator-Selected Therapy in Adults With Advanced or Metastatic Urothelial Carcinoma Previously Treated With Platinum Chemotherapy and PD-L1 Inhibitors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of SHR-A2102 for injection compared to investigator-selected therapies in patients with locally advanced or metastatic urothelial carcinoma. These patients have previously received platinum-based chemotherapy and PD-L1 inhibitors. This Phase III clinical trial aims to better understand treatment options for this advanced cancer stage and is sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd. The study randomly assigns participants to receive either SHR-A2102 for injection or one of several approved therapies chosen by the investigator, including Docetaxel, Paclitaxel, Gemcitabine Hydrochloride, or Pemetrexed Disodium injections. Participants receive treatment according to the assigned group, and the trial monitors responses and safety over time. During the trial, participants will be regularly assessed for progression-free survival and overall survival up to approximately 1.5 to 2 years. Researchers will also evaluate response rates, disease control, treatment duration, serum drug concentrations, antibody formation, and adverse events. The study involves multiple evaluations including imaging and laboratory tests to monitor disease status and treatment effects throughout the participation period, which may last up to two years.

A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma