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NCT06561555
A Study on the Efficacy of Disitamab Vedotin in Advanced HER2-positive Paget's Disease.
Phase 2 trial testing RC48 in Mammary or Extramammary Paget's Disease in 36 participants. Currently enrolling.
15 August 2025
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 15 August 2024 |
| Primary completion | 15 August 2025 |
| Estimated completion | 15 August 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- RC48 — full drug profile →
Conditions studied
- Mammary or Extramammary Paget's Disease — all drugs for Mammary or Extramammary Paget's Disease →
Sponsor
Fudan University
Who can join
Adults 18 to 75, any sex, with Mammary or Extramammary Paget's Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a single-center, phase II clinical trial. Patients with HER2-positive advanced breast and 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 trastuzumab deruxtecan intravenous infusion every 3 weeks until disease progression. Follow-up was conducted until disease progression, 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06561555
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of RC48
Trials testing the same drug.
- NCT07474324 — Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage · Phase 2 · recruiting
- NCT07172217 — The Efficacy and Safety RC48 Plus QL1706 in Second-Line Treatment of HER2-Expressing Recurrent CC · Phase 2 · not yet recruiting
- NCT06663007 — RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure · Phase 1, PHASE2 · recruiting
- NCT06385873 — RC48 Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer · Phase 2 · not yet recruiting
- NCT05957757 — RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression · Phase 2 · recruiting
Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06561555 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 17 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06561555.
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