OncoMatch/Clinical Trials/NCT07117851
A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease
Is NCT07117851 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Disitamab Vedotin combined with Bicalutamide for extramammary paget disease.
Treatment: Disitamab Vedotin combined with Bicalutamide — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC ≥ 1+)
pathologically confirmed as HER2 positive, i.e., immunohistochemical test HER2 ≥ 1+
Required: AR overexpression (IHC ≥ 1+)
AR positive, i.e., immunohistochemical test AR ≥ 1+
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, Platelet ≥70×10^9/L, Hemoglobin ≥80g/L
Kidney function
Serum Creatinine ≤1.5×ULN, or Creatinine Clearance ≥50 mL/min
Liver function
Total Bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN; Serum Albumin ≥28 g/L; ALP ≤5×ULN
Adequate organ function: Blood routine: Absolute Neutrophil Count (ANC) ≥1.5×10^9/L, Platelet (PLT) ≥70×10^9/L, Hemoglobin (HGB) ≥80g/L; Liver function: Total Bilirubin (TBIL) ≤1.5×ULN; Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3×ULN; Serum Albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; ... Renal function: Serum Creatinine (Cr) ≤1.5×ULN, or Creatinine Clearance ≥50 mL/min (using the standard Cockcroft-Gault formula): Coagulation function: International Normalized Ratio (INR) ≤1.5 / Prothrombin Time (PT) ≤1.5×ULN, Activated Partial Thromboplastin Time (aPTT) ≤1.5×ULN; - If the subject is receiving anticoagulant therapy, as long as PT and INR are within the range specified for the anticoagulant medication, it is acceptable.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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