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OncoMatch/Clinical Trials/NCT06592326

9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer

Is NCT06592326 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including 9MW2821 and Toripalimab for urothelial carcinoma.

Phase 3RecruitingMabwell (Shanghai) Bioscience Co., Ltd.NCT06592326Data as of May 2026

Treatment: 9MW2821 · Toripalimab · Gemcitabine · Cisplatin/CarboplatinThis is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-PD-1/PD-L1/PD-L2 or CTLA-4 inhibitor

Previously treated with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors

Cannot have received: antibody-drug conjugate

Exception: ADCs which target Nectin-4 or are conjugated with payload MMAE

Previously treated with ADCs which target Nectin-4 or are conjugated with payload MMAE

Cannot have received: radiation therapy

Exception: within 21 days

Radiotherapy or Intravesical therapy treated within 21 days

Cannot have received: major surgery

Exception: within 28 days

Major surgery treated within 28 days

Cannot have received: live vaccine

Exception: within 28 days

Any live vaccines got within 28 days

Cannot have received: traditional Chinese medicine

Exception: within 14 days

Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days

Lab requirements

Blood counts

Kidney function

Liver function

Adequate organ functions.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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