RecruitingPhase 2NCT05943379

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)


Sponsor

RemeGen Co., Ltd.

Enrollment

85 participants

Start Date

Jun 8, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — RC48 (an antibody-drug treatment) and gemcitabine (a chemotherapy) — in people with high-risk bladder cancer that has not yet invaded the bladder muscle. Participants must have already had surgery to remove visible tumors from the bladder lining. **You may be eligible if...** - You are 18 or older - You have been diagnosed with high-risk non-muscle-invasive bladder cancer (confirmed by pathology) - You have completed a procedure called TURBT (surgery to remove bladder tumors) within the past 3 weeks - Your cancer is staged as T1, high-grade, or multiple/recurrent tumors - You have not yet received any drug treatment for this cancer **You may NOT be eligible if...** - You have cancer that has spread into the bladder muscle or beyond - You have already received drug treatment for bladder cancer - You are unable or unwilling to give informed consent Talk to your doctor to see if this trial is right for you.

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

DRUGRC48-ADC in Combination with gemcitabine

RC48-ADC IV (intravenous) 2.0mg/kg IV, Q2W, 8W; Q4W, 40W Gemcitabine Intravesical 1000mg induction QW,8W; maintenance Q4W,40W


Locations(1)

Peking University First Hosptital

Beijing, Beijing Municipality, China

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NCT05943379


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