OncoMatch/Clinical Trials/NCT06791070
A Study of RC48-ADC Combined With JS001 for Advanced Extramammary Paget Disease of the Scrotum
Is NCT06791070 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Disitamab Vedotin combined with Toripalimab for paget disease, extramammary.
Treatment: Disitamab Vedotin combined with Toripalimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC ≥ 1+)
pathologically confirmed as HER2 positive, i.e., immunohistochemical test HER2 ≥ 1+
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, Platelet (PLT) ≥70×10^9/L, Hemoglobin (HGB) ≥80g/L
Kidney function
Serum Creatinine (Cr) ≤1.5×ULN, or Creatinine Clearance ≥50 mL/min
Liver function
Total Bilirubin (TBIL) ≤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 ... Coagulation function: INR ≤1.5 / PT ≤1.5×ULN, aPTT ≤1.5×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06791070 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify