A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRemeGen Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Expected survival ≥12 weeks.
Locally advanced unresectable or metastatic UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra.
At least one measurable lesion based on RECIST version 1.1
HER2-expressing status determined by the central laboratory to be IHC 1+, 2+ or 3+.
Disqualifiers
Known hypersensitivity to RC48-ADC or Toripalimab or any of its components.
History of major surgery within 4 weeks of planned start of trial treatment.
Toxicity from a previous treatment has not returned to Grade 0-1.
Prior ADCs or PD-1/PD-L1 inhibitor therapy.
Trial design
Treatments tested in this trial
- RC48-ADC
- Toripalimab
- Gemcitabine
- Cisplatin
- Carboplatin
Treatment groups
452 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov