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 (Jun 2026). This Phase 3 trial studies multiple treatments for urothelial carcinoma.
Treatment: RC48-ADC · Toripalimab · Gemcitabine · Cisplatin · Carboplatin — This 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
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
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.
Frequently asked questions
Is NCT05302284 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages