Phase II Study of Trastuzumab Rezetecan Alone or With Adebrelimab for HER2-Positive Advanced or Metastatic Urothelial Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Trastuzumab Rezetecan SHR-A1811, alone or combined with Adebrelimab SHR-1316, in treating HER2-expressing locally advanced or metastatic urothelial carcinoma lamUC. This multicenter, open-label Phase II trial focuses on three patient groups based on their prior treatments and disease progression to gain important insights on these therapies for advanced urothelial cancer. Participants receive either Trastuzumab Rezetecan alone or combined with Adebrelimab every three weeks, depending on their prior treatment history. The study includes three cohorts those with prior systemic therapy and recent relapse, those without prior systemic therapy or late relapse, and those previously treated with platinum-based chemotherapy, immunotherapy, or Disitamab Vedotin. The trial aims to provide data on the combination therapys potential as a new treatment option. During the study, participants will have measurable target lesions assessed according to RECIST 1.1 criteria and monitored for treatment response, progression-free survival, overall survival, disease control, response duration, and time to response over approximately 36 months. Safety is evaluated through adverse event reporting, and quality of life is assessed using specific questionnaires. Participants undergo regular laboratory tests, performance status assessments, and pregnancy testing when applicable, with follow-up continuing for up to three years.

Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)