9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
NCT06823427 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-03-21
Summary
This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.
Conditions
- Urothelial Carcinoma
- Urothelial Carcinoma Bladder
- Urothelial Carcinoma Recurrent
- Urothelial Carcinoma of the Renal Pelvis and Ureter
Interventions
- DRUG
-
9MW2821
a nectin-4 ADC with MMAE payload
- DRUG
-
Toripalimab (JS001 )
anit-PD-1 antibody
Sponsors & Collaborators
-
Mabwell (Shanghai) Bioscience Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-17
- Primary Completion
- 2026-06-30
- Completion
- 2027-06-30
Countries
- China
Study Locations
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