NCT06178601

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

An Open-label, Single-arm, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of RC48-ADC Combined With AK104 in HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Shanxi Province Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of RC48-ADC combined with AK104 in HER2-expression locally advanced or metastatic urothelial carcinoma.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	RC48-ADC	RC48-ADC （2.0 mg/kg，intravenous (IV) infusion，Q2W）, combined with cadonilimab（AK104）
DRUG	AK104	AK104（6.0 mg/kg，intravenous (IV) infusion，Q2W）combined with RC48-ADC

Timeline

• Start date: 2023-08-03
• Primary completion: 2024-09-01
• Completion: 2026-04-01
• First posted: 2023-12-21
• Last updated: 2023-12-21

Locations

2 sites across 1 country: China