NCT06791070

A Study of RC48-ADC Combined With JS001 for Advanced Extramammary Paget Disease of the Scrotum

A Prospective Multicenter Clinical Trial on the Efficacy and Safety of RC48-ADC (Disitamab Vedotin) Combined With Toripalimab in Advanced HER2-positive Extramammary Paget Disease of the Scrotum

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Disitamab Vedotin combined with Toripalimab works to treat advanced HER2-positive extramammary Paget disease of the scrotum. It will also learn about the safety of this combination. The main questions it aims to answer are: Does this combination reduce tumor volume and delay disease progression? What medical problems do participants have when receving this combination? Participants will: Intravenous using this combination every 3 weeks until disease progression or intolerable adverse reactions occur. Visit the clinic once every 3 weeks for checkups and tests.

Detailed description

This study is a multiple-center, phase II clinical trial. Participants with HER2-positive advanced scrotal extramammary Paget's disease who met the eligibility criteria were enrolled after signing an informed consent form. All patients received treatment with 2mg/kg of Disitamab Vedotin and 3mg/kg of Toripalimab intravenous infusion every 3 weeks until disease progression. Follow-up was conducted until disease progression, intolerable adverse reactions, withdrawal of informed consent by the participant, loss to follow-up, or death. The area of the largest lesion on the scrotal skin was measured and clinical tumor imaging assessments were performed using RECIST during the treatment process.

Conditions

• Paget Disease, Extramammary
• Scrotum Disease

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin combined with Toripalimab	Disitamab Vedotin at a dosage of 2mg/kg and 3mg/kg of Toripalimab administered intravenously every 3 weeks (ivgtt q3w) is continued until disease progression, with the allowance for treatment discontinuation due to disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antineoplastic therapy, or other reasons specified in the protocol, with the earliest occurring event taking precedence. Alternatively, the study investigator may determine the need to discontinue treatment.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: China