A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study of SHR-A2102 for Injection Versus Investigator-selected Therapy in Locally Advanced or Metastatic Urothelial Carcinoma Previously Treated With Platinum-Containing Chemotherapy and PD-(L)1 Inhibitors and With or Without ADC
To evaluate the efficacy and safety of SHR-A2102 for injection versus Investigator-selected Therapy in patients with Locally advanced or Metastatic Urothelial Carcinoma who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.
• Voluntarily participate in this clinical study, understand the study procedures and be able to sign the informed consent form in writing.
• 18 to 80 years old (including boundary value), gender is not limited.
• ECOG performance status score of 0 or 1.
• Estimated survival ≥ 3 months.
• Pathologically confirmed urothelial carcinoma confirmed by imaging or other methods as locally advanced unresectable or metastatic disease.
• Patients with locally advanced or metastatic disease who have previously received both a platinum-based chemotherapy regimen and a PD-(L)1 inhibitor; patients who received platinum-based chemotherapy and/or a PD-(L)1 inhibitor as neoadjuvant or adjuvant therapy and experienced recurrence or progression during treatment or within 6 months after completing treatment will be considered to have received these therapies in the locally advanced/metastatic setting.
• Imaging-confirmed disease progression during or after treatment with the most recent regimen.
• Able to provide preserved or fresh tumor tissue.
• Must be present with at least one measurable lesion according to RECIST v1.1 criteria.
⁃ Good level of organ function.
⁃ Male subjects whose partners are women of childbearing potential and female subjects of childbearing potential must use highly effective contraception from the time of signing the informed consent form until 8 months after the last dose of the trial drug.