A Clinical Study on the Safety and Efficacy of 9MW2821 in Patients With High-risk Non-muscle-invasive Bladder Cancer (NMIBC) That Have Previously Failed to Intravesical Therapy
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.
• 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).