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OncoMatch/Clinical Trials/NCT05302284

A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

Is NCT05302284 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for urothelial carcinoma.

Phase 3RecruitingRemeGen Co., Ltd.NCT05302284Data as of May 2026

Treatment: RC48-ADC · Toripalimab · Gemcitabine · Cisplatin · CarboplatinThis is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression (ihc 1+, 2+ or 3+)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: antibody-drug conjugate

Prior ADCs

Cannot have received: anti-PD-1 therapy

Prior PD-1/PD-L1 inhibitor therapy

Cannot have received: anti-PD-L1 therapy

Prior PD-1/PD-L1 inhibitor therapy

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

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

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