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

Trial Details

NCT ID

NCT06378242

Phase

PHASE1 / PHASE2

Sponsor

RemeGen Co., Ltd.

Status

RECRUITING

Cancer Type

Bladder Cancer

Interventions

• Disitamab Vedotin for injection

Locations (sample)

• Guangzhou, Guangdong, China|23.11667,113.25
• Wuhan, Hubei, China|30.58333,114.26667
• Changsha, Hunan, China|28.19874,112.97087
• Nanjing, Jiangsu, China|32.06167,118.77778
• Chengdu, Sichuan, China|30.66667,104.06667

Key Eligibility Criteria

• Voluntary consent to participate in the study and signed the informed consent form.
• Male or female, age 18-75 years (including both).
• Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.
• Note: High-risk NMIBC is a high-grade / G3 tumor meeting any of the following:

For full eligibility, visit ClinicalTrials.gov.

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