Actively Recruiting
A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2025-04-13
432
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study was to compare the antitumor activity of 9MW2821 and chemotherapy in participants with locally advanced or metastatic urothelial cancer previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy.
CONDITIONS
Official Title
A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent approved by an ethics board
- Male or female aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically confirmed locally advanced or metastatic urothelial cancer not suitable for curative surgery
- Previously treated with platinum chemotherapy and PD-(L)1 inhibitor in metastatic or locally advanced setting
- If treated with platinum or PD-(L)1 inhibitor in adjuvant/neoadjuvant setting, progressed during treatment or within 12 months after completion
- Experienced radiographic progression during or after last treatment
- Able to provide archival or fresh tumor tissue sample
- Life expectancy of at least 12 weeks
- Measurable disease based on RECIST version 1.1
- Adequate organ function
- Sexually active subjects and partners agree to use contraception during study and for 6 months after
- Willing to follow study procedures
You will not qualify if you...
- Received chemotherapy or radiotherapy within 21 days before first study drug dose
- Used traditional Chinese medicine with anticancer effects within 14 days before first study drug dose
- Used investigational drugs or devices within 28 days before first study drug dose
- Previously treated with nectin-4 targeted ADC or ADC with MMAE payload
- Prior chemotherapy with all control arm therapies
- Used strong CYP3A4 inducers/inhibitors within 14 days before first study drug dose
- Existing treatment-related toxicity grade 2 or higher (except alopecia and stable grade 2 endocrine toxicity)
- Major surgery within 28 days before first study drug dose
- Hemoglobin A1C (HbA1c) of 8% or higher
- Peripheral neuropathy grade 2 or higher
- Any live vaccines within 28 days before or during study
- Significant cardiac or cerebrovascular disease within 6 months before first study drug dose
- Severe or uncontrolled diseases such as severe respiratory disease, thromboembolic events, active bleeding or infection
- Central nervous system metastases
- History of another malignancy within 3 years (except cured cancers)
- Autoimmune disease requiring systemic treatment within 2 years before first study drug dose
- Eye conditions increasing risk of corneal damage
- Known sensitivity to study drug ingredients, history of drug abuse or mental illness
- Uncontrolled tumor-related bone pain or spinal cord compression not stable for at least 2 weeks
- Pleural effusion, ascites, or pericardial effusion with symptoms or requiring drainage
- Any condition putting participant at significant risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
D
Dingwei Ye, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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