OncoMatch/Clinical Trials/NCT06551233
Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)
Is NCT06551233 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies 9MW2821 for bladder cancer.
Treatment: 9MW2821 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage NON-MUSCLE-INVASIVE
Excluded: Stage MUSCLE INVASIVE, IV
Clinical non-metastatic bladder cancer (N0, M0) determined by CT scan. 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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: intravesical therapy (BCG, gemcitabine)
Subjects must have previously failed to at least one kind of intravesical therapy, including but not limited to BCG, gemcitabine, etc.
Cannot have received: systemic anti-cancer therapy
Other systemic anti-cancer therapies within 3 weeks before the first dose of the study drug.
Cannot have received: Nectin-4 targeted therapy
Prior treatment with drugs targeted Nectin-4
Cannot have received: MMAE-conjugated antibody-drug conjugate
Prior treatment with drugs targeted...MMAE-conjugated ADC
Lab requirements
Blood counts
adequate function of bone marrow
Kidney function
adequate function of kidney
Liver function
adequate function of liver
Cardiac function
adequate function of heart
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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