Trials / Recruiting
RecruitingNCT06823427
9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
A Randomized Phase II Trial to Evaluate 9MW2821 in Combination With Toripalimab Compared With 9MW2821 Monotherapy for the 1st Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | 9MW2821 | a nectin-4 ADC with MMAE payload |
| DRUG | Toripalimab (JS001 ) | anit-PD-1 antibody |
Timeline
- Start date
- 2025-01-17
- Primary completion
- 2026-06-01
- Completion
- 2027-06-01
- First posted
- 2025-02-12
- Last updated
- 2025-03-21
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06823427. Inclusion in this directory is not an endorsement.