Status:
RECRUITING
Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- Age≥18 years old before signing the informed consent.
- Subjects must have previously failed to at least one kind of intravesical therapy, including but not limited to BCG, gemcitabine, etc.
- Subjects refuse or are intolerant to BCG therapy.
- Subjects must have completed a standard TURBT surgery within 6 weeks before the first dose of the study drug and have no evidence of residual tumors in the surgical field.
- Tumor tissue samples from TURBT must be provided (≥5 slides), along with relevant pathological reports.
- Histological and pathological diagnosis of urothelial carcinoma (with a major component \>50%) , with the confirmation of no-muscle invasion.
- Subjects must be categorized as high-risk NMIBC
- Subjects refuse or are intolerant to radical cystectomy.
- Clinical non-metastatic bladder cancer (N0, M0) determined by CT scan.
- Adequate function of heart, bone marrow, liver, and kidney.
- ECOG 0-1
- Subjects must be willing to take highly effective contraception during the study and 180 days after the last dose of 9MW2821 (a negative serum pregnancy test result within ≤7 days before enrollment for the female).
Exclusion
- History of muscle invasive or metastatic bladder cancer.
- History of other malignancies within 3 years.
- Other systemic anti-cancer therapies within 3 weeks before the first dose of the study drug.
- Surgery (such as TURBT) or radiotherapy for bladder lesions within 2 weeks before the first dose.
- Hypersensitivity reactions to certain components of 9MW2821 or similar drugs.
- Persistence of adverse reactions caused by prior anti-tumor therapy before the first dose, does not recover to grade 1 and below, according to NCI-CTCAE v5.0.
- Active systemic infections that require treatments within 7 days before the first dose.
- Severe cardiovascular diseases within 6 months before the first dose.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- History of autoimmune diseases.
- Serum virology tests: positive results for HBsAg or HBcAb, with positive HBV-DNA copies (≥500IU/mL); positive HCV-Ab results, with positive HCV-RNA results; positive HIV-Ab results.
- Prior treatment with drugs targeted Nectin-4 or MMAE-conjugated ADC.
Key Trial Info
Start Date :
April 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06551233
Start Date
April 22 2024
End Date
December 31 2025
Last Update
August 13 2024
Active Locations (1)
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1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China