Actively Recruiting
Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2024-08-13
30
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.
CONDITIONS
Official Title
Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older before signing informed consent
- Previously failed at least one intravesical therapy, including BCG or gemcitabine
- Refuse or are intolerant to BCG therapy
- Completed standard TURBT surgery within 6 weeks before first dose with no residual tumors
- Provide tumor tissue samples from TURBT (at least 5 slides) and relevant pathology reports
- Diagnosed with urothelial carcinoma with more than 50% major component and no muscle invasion
- Categorized as high-risk NMIBC
- Refuse or intolerant to radical cystectomy
- Clinical non-metastatic bladder cancer confirmed by CT scan (N0, M0)
- Adequate heart, bone marrow, liver, and kidney function
- ECOG performance status 0-1
- Willing to use highly effective contraception during study and 180 days after last dose, with negative pregnancy test within 7 days before enrollment for females
You will not qualify if you...
- History of muscle-invasive or metastatic bladder cancer
- History of other cancers within 3 years
- Received systemic anti-cancer therapy within 3 weeks before first dose
- Surgery or radiotherapy for bladder lesions within 2 weeks before first dose
- Hypersensitivity to 9MW2821 components or similar drugs
- Ongoing adverse reactions from prior anti-tumor therapy above grade 1
- Active systemic infections requiring treatment within 7 days before first dose
- Severe cardiovascular disease within 6 months before first dose
- History of stem cell or organ transplantation
- History of autoimmune diseases
- Positive tests for hepatitis B or C with active virus or positive HIV
- Prior treatment with drugs targeting Nectin-4 or MMAE-conjugated ADC
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
G
Guo Hongqian, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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