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Disitamab Vedotin (RC48)

DRUG8 trials

Sponsors

Fudan University, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Peking University First Hospital, West China Hospital

Conditions

Advanced Breast CancerBladder CancerBladder Urothelial CarcinomaBreast CancerHER2 + Breast CancerHER2-low Breast CancerHER2-negative Breast CancerMIBC

Phase 2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
RecruitingNCT06649331
Fudan UniversityAdvanced Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer (TNBC) +2
Start: 2024-10-21End: 2027-09-01Target: 160Updated: 2026-09-03
RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
RecruitingNCT07065435
The First Affiliated Hospital with Nanjing Medical UniversityHER2 + Breast Cancer
Start: 2024-01-01End: 2026-01-01Target: 74Updated: 2025-07-15
Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study
RecruitingNCT07093866
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolmCRPC
Start: 2025-07-20End: 2027-12-30Target: 20Updated: 2025-07-30
Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
RecruitingNCT07446452
The First Affiliated Hospital with Nanjing Medical UniversityHER2-low Breast Cancer
Start: 2024-01-01End: 2027-01-01Target: 37Updated: 2026-03-03
Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
Not yet recruitingNCT07498907
Peking University First HospitalUpper Tract Urothelial Carcinoma
Start: 2026-05-01End: 2034-03-01Target: 192Updated: 2026-03-27
HOPE-07-MIBC: Disitamab Vedotin Plus Immunotherapy vs Chemoimmunotherapy in Resectable HER2-Expressing MIBC
Not yet recruitingNCT07608224
West China HospitalUrinary Bladder Neoplasms
Start: 2026-06-20End: 2030-12-31Target: 240Updated: 2026-05-27
Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer
Not yet recruitingNCT07756008
Tianjin Medical University Second HospitalBladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer, Bladder Cancer
Start: 2026-08-01End: 2031-06-20Target: 114Updated: 2026-08-10

Phase 3

Neoadjuvant RC48 Plus Gemcitabine in HER2-Expressing MIBC
RecruitingNCT07693959
Zhiquan HuMIBC
Start: 2026-07-01End: 2029-07-01Target: 170Updated: 2026-07-09