NCT07117851

A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease

A Prospective, Single-Arm Clinical Study of Disitamab Vedotin Combined With Bicalutamide in HER2 and AR-Expressing Scrotal Paget's Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Disitamab Vedotin combined with Bicalutamide works to treat advanced HER2-positive and AR- positive extramammary Paget disease of the scrotum. It will also learn about the safety of this combination. All patients received Disitamab Vedotin every 2 weeks and Bicalutamide everyday. Follow-up was conducted until disease progression, intolerable adverse reactions occur withdrawal of informed consent by the subject, loss to follow-up, or death. Clinical tumor imaging assessments were performed using RECIST during the treatment process.

Conditions

• Extramammary Paget Disease
• Scrotum Disease

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin combined with Bicalutamide	Single Group Assignment

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: China