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

NCT06738251 Phase 3 RECRUITING

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.

Details

Lead sponsor	Shanghai Hengrui Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	RECRUITING
Enrolment	402
Start date	2025-02-12
Completion	2027-09

Conditions

• Advanced Urothelial Carcinoma

Interventions

• SHR-A2102 for Injection
• Docetaxel Injection
• Paclitaxel Injection
• Gemcitabine Hydrochloride for Injection
• Pemetrexed Disodium for Injection

Primary outcomes

• Progression-free Survival (PFS) — Up to approximately 1.5 years.
• Overall Survival (OS) — Up to approximately 1.5 years and 2 years.

Countries

China