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RECRUITING
NCT06378242
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-06-14

Completion Date

2029-12-31

Last Updated

2024-07-11

Healthy Volunteers

No

Interventions

DRUG

Disitamab 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