Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT07241793
Brief Summary:
This is a multicenter, open-label, Phase II clinical trial to evaluate the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC).
Detailed Description:
This multicenter Phase II study aims to investigate the clinical efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC). The study includes three cohorts based on their prior treatment history and relapse/progression status: Cohort 1 includes patients who have received at least one prior systemic therapy and relapsed/progressed within 12 months; Cohort 2 includes patients who have not received prior systemic therapy or relapsed/progressed more than 12 months after neo-adjuvant/adjuvant treatment; Cohort 3 includes patients who have previously received platinum-based chemotherapy, immunotherapy, or Disitamab Vedotin. The study will provide important data on the combination therapy of Trastuzumab Rezetecan and Adebrelimab, potentially offering a new treatment option for patients with HER2-expressing advanced UC .
Study:
NCT07241793
Study Brief:
Protocol Section:
NCT07241793