Actively Recruiting
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
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2025-03-21
60
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of combining 9MW2821 with toripalimab compared to using 9MW2821 alone in patients with locally advanced or metastatic urothelial carcinoma who have not yet received systemic treatment for their advanced cancer. This randomized phase II trial aims to improve first-line treatment options for this condition, which includes urothelial carcinoma of the bladder, renal pelvis, and ureter. Participants will be assigned to receive either the combination of 9MW2821, a nectin-4 antibody-drug conjugate with MMAE payload, plus toripalimab, an anti-PD-1 antibody, or 9MW2821 monotherapy. The study treatments will be given according to protocol, with no masking or blinding. The trial includes a planned 3-year period to assess treatment response and safety. Throughout the study, participants will undergo regular assessments including evaluations of tumor response using RECIST v1.1 criteria, safety monitoring, and immunogenicity tests over three years. Researchers will measure outcomes such as the objective response rate and other efficacy endpoints. Participants must be able to follow study visits, treatment, and laboratory procedures, with contraceptive measures maintained until 180 days after the last dose. The overall participation spans from screening through treatment and follow-up over the study duration.
CONDITIONS
Brief Title
9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation
- 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, and ureter
- Mixed histology allowed if urothelial carcinoma differentiation is greater than 50%
- No prior systemic treatment for locally advanced or metastatic urothelial carcinoma
- At least one measurable target lesion according to RECIST v1.1
- Life expectancy over 12 weeks
- Appropriate blood and organ function
- Agree to use contraceptive measures until 180 days after last study drug dose
- Able to understand and follow study visits, treatment, and assessments
You will not qualify if you...
- Other cancers within 3 years before randomization
- Active autoimmune disease requiring systemic treatment within 2 years
- Recent high-dose corticosteroid or immunosuppressive use
- Severe cardiovascular or cerebrovascular events within 6 months
- Major surgery within 28 days before randomization
- Recent live vaccine within 28 days or planned during study
- Radiotherapy or bladder infusion therapy within 21 days prior
- Use of strong CYP3A4 inhibitors within 14 days prior
- Lung effusion or ascites needing treatment within 14 days
- Severe uncontrolled bone pain or spinal cord compression within 14 days
- Active infection needing systemic antibiotics within 7 days
- Prior treatment with anti-PD-1, anti-PD-L1/PD-L2, anti-CTLA-4, Nectin-4 targeted therapy, or ADC with MMAE
- Prior stem cell or solid organ transplant
- Unresolved toxicities from previous cancer treatments except alopecia and skin changes
- Severe dry eyes, keratitis, corneal ulceration, or corneal disease risks
- Preexisting grade 2 or higher neuropathy
- Other uncontrolled serious illness
- Brain metastasis or meningeal carcinomatosis
- Positive for HBsAg and HBV-DNA, HCV-Ab and HCV-RNA, or HIV-Ab
- Known allergy to study drugs or components
- Drug abuse or psychiatric disorder affecting compliance
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants receive 9MW2821 with or without toripalimab as the first-line treatment for locally advanced or metastatic urothelial carcinoma.
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
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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