drugset / Trial / NCT07117851
A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease
Phase 2
Recruiting
20 enrolled
Fudan University
Fujian Province Tumor Hospital · collabQinghai Province Fifth People's Hospital · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-01
- Primary completion
- 2027-12-30
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bicalutamide | Other / unclassified | — | — |
| Subject | Disitamab Vedotin | Monoclonal antibody | — | — |