RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
An Open-label, Single Arm, Single Center Phase 2 Study of RC48-ADC (IV) in Combination With Gemcitabine(Intravesical) in High Risk NMIBC Subjects (BCG Naïve or BCG Unresponsive) That Expresses HER2 (IHC 1+ and Greater)
RemeGen Co., Ltd.
85 participants
Jun 8, 2023
INTERVENTIONAL
Conditions
Summary
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in combination with gemcitabine.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
RC48-ADC IV (intravenous) 2.0mg/kg IV, Q2W, 8W; Q4W, 40W Gemcitabine Intravesical 1000mg induction QW,8W; maintenance Q4W,40W
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05943379