A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma
Trial Parameters
Brief Summary
The study is being conducted to evaluate the efficacy of SHR-A2102 with adebrelimab versus gemcitabine in combination with cisplatin/carboplatin in previously untreated locally advanced or metastatic urothelial carcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Be able to sign the informed consent form in writing. 2. Female or male, 18 to 80 years of age (both inclusive). 3. ECOG performance status of 0 or 1. 4. Expected survival of≥ 3 months. 5. Histologically confirmed diagnosis of urothelial carcinoma with radiographic or other confirmation of locally advanced unresectable or metastatic disease. 6. No prior systemic therapy for locally advanced or metastatic disease. 7. Able to provide archived or fresh tumor tissue for Nectin-4 and PD-L1 expression. 8. According to RECIST v1.1, there must be at least one measurable lesion; 9. Tolerant to cisplatin or carboplatin. 10. Adequate organ functions. 11. Agree to use medically approved contraceptive measures. Exclusion Criteria: 1. Planned to receive any other anti-tumor therapy during the study. 2. Received other investigational products or treatments not yet marketed within 4 weeks. 3. Have received systemic anti-tumor treatment within 4 weeks;have received prior anti-tum