Actively Recruiting
9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2025-03-21
60
Participants Needed
2
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate
- Age between 18 and 80 years
- ECOG performance status of 0 or 1
- Histologically confirmed inoperable locally advanced or metastatic urothelial carcinoma (including bladder, renal pelvis, or ureter)
- Mixed histology allowed if urothelial carcinoma differentiation is over 50%
- No prior systemic treatment for locally advanced or metastatic urothelial carcinoma
- At least one measurable target lesion per RECIST v1.1 criteria
- Target lesion outside radiation field or showing progression if previously irradiated
- Life expectancy greater than 12 weeks
- Adequate blood and organ function
- Agree to use contraception until 180 days after last study drug dose
- Able to understand and comply with study visits, treatments, and assessments
You will not qualify if you...
- Other cancers within 3 years before randomization
- Active autoimmune disease needing systemic treatment within 2 years prior
- Use of high-dose corticosteroids or immunosuppressive drugs recently
- Severe cardiovascular or cerebrovascular events within 6 months before randomization
- Major surgery within 28 days before randomization
- Live vaccine within 28 days before or during the study
- Radiotherapy or bladder infusion therapy within 21 days before randomization
- Use of strong CYP3A4 inhibitors within 14 days before randomization
- Lung effusion or ascites needing treatment within 14 days before randomization
- Severe uncontrolled bone pain or spinal cord compression within 14 days
- Active infection requiring systemic antibiotics within 7 days before randomization
- Prior treatment with anti-PD-1, anti-PD-L1/PD-L2, anti-CTLA-4, or Nectin-4 targeted therapies
- Previous hematological stem cell or solid organ transplant
- Unresolved toxicities from prior cancer treatments above grade 1 except hair loss or skin pigmentation
- Severe dry eyes, active keratitis, corneal ulcers, or other corneal risks deemed unsuitable
- Preexisting neuropathy grade 2 or higher
- Other uncontrolled serious illnesses
- Brain metastasis or meningeal carcinomatosis
- Positive for hepatitis B, hepatitis C, or HIV infections
- Known allergy to study drugs or components
- Drug abuse or psychiatric conditions affecting study compliance
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hunan Tumor Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
2
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
J
Jia Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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