RecruitingPhase 1Phase 2NCT06378242

To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2

An Single-arm, Multicenter Phase I/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2


Sponsor

RemeGen Co., Ltd.

Enrollment

24 participants

Start Date

Jun 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing disitamab vedotin — a targeted antibody-drug combination (ADC) that is delivered directly into the bladder — in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) whose tumors express a protein called HER2. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed non-muscle-invasive bladder cancer classified as high-risk or very high-risk (including CIS, T1 stage, tumors larger than 3cm, or multiple/recurrent tumors) - Your tumor has been shown to express HER2 through testing - You have already had tumor removal surgery (TURBT) but still have residual CIS - You are not a candidate for radical bladder removal surgery, or you have declined it **You may NOT be eligible if...** - Your tumor does not express HER2 - Your bladder cancer has invaded the muscle layer - You have not undergone TURBT - You have other conditions that would make treatment unsafe 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

DRUGDisitamab Vedotin for injection

Intravesical instiliations into the bladder


Locations(6)

Sun Yat-sen Memorial Hospital,SunYat-sen University

Guangzhou, Guangdong, China

Tongji Hospital

Wuhan, Hubei, China

Hunan Cancer hospital

Changsha, Hunan, China

The first affiliated hospital with nanjing medical universtity

Nanjing, Jiangsu, China

West China Hospital

Chengdu, Sichuan, China

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06378242