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OncoMatch/Clinical Trials/NCT06178601

A Study of RC48-ADC Combined With Cadonilimab(AK104)in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma

Is NCT06178601 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including RC48-ADC and AK104 for urothelial carcinoma.

Phase 2RecruitingShanxi Province Cancer HospitalNCT06178601Data as of May 2026

Treatment: RC48-ADC · AK104This study will evaluate the efficacy and safety of RC48-ADC combined with AK104 in HER2-expression 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+)

HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab

Disease stage

Metastatic disease required

locally advanced or metastatic 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: antitumor therapy

Has received other antitumor therapy before planned start of trial treatment

Lab requirements

Blood counts

Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment

Kidney function

Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment

Liver function

Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment

Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment

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

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