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

NCT06791070 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-24

No results posted yet for this study

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.

Conditions

  • Paget Disease, Extramammary
  • Scrotum Disease

Interventions

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.

Sponsors & Collaborators

  • Zhejiang Tumor Hospital

    collaborator OTHER

  • Fujian Provincial Hospital

    collaborator OTHER

  • Zhangzhou Affiliated Hospital of Fujian Medical University

    collaborator OTHER

  • Quanzhou First Hospital

    collaborator OTHER

  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • Fujian Medical University Union Hospital

    lead OTHER

Principal Investigators

  • Shaoxing Zhu, Doctor · Fujian Medical University Union Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2027-01-31
Completion
2028-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06791070 on ClinicalTrials.gov