A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma
NCT06738251 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402
Last updated 2025-07-17
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
- 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.
Sponsors & Collaborators
-
Shanghai Hengrui Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-12
- Primary Completion
- 2026-07-31
- Completion
- 2027-09-30
Countries
- China
Study Locations
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