NCT06738251

A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	SHR-A2102 for Injection	SHR-A2102 for Injection.
DRUG	Docetaxel Injection	Docetaxel Injection.
DRUG	Paclitaxel Injection	Paclitaxel Injection.
DRUG	Gemcitabine Hydrochloride for Injection	Gemcitabine Hydrochloride for Injection.
DRUG	Pemetrexed Disodium for Injection	Pemetrexed Disodium for Injection.

Timeline

• Start date: 2025-02-12
• Primary completion: 2026-07-01
• Completion: 2027-09-01
• First posted: 2024-12-17
• Last updated: 2025-07-17

Locations

1 site across 1 country: China