8 recruiting, 4 unknown, 3 active not recruiting, 2 not yet recruiting. 13 Phase 2, 6 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Recruiting 5, Unknown 4, Active not recruiting 2, Not yet recruiting 2 |
| Phase 3 | 6 | Recruiting 3, Not yet recruiting 2, Active not recruiting 1 |
| Phase 1 | 1 | Unknown 1 |
Follow RC48 antibody: new trials by email Literature Review of RC48 antibody trials Research Report on RC48 antibody
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer Disitamab Vedotin (RC48), Toripalimab, Transurethral Resection of Bladder Tumor - Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer | Phase 2 / Phase 3 | Not yet recruiting | Tianjin Medical University Second Hospital | 114 | 2026-08-01 | 2026-08-10 |
| Neoadjuvant RC48 Plus Gemcitabine in HER2-Expressing MIBC Gemcitabine, Toripalimab, Disitamab Vedotin (RC48) - MIBC | Phase 3 | Recruiting | Zhiquan Hu | 170 | 2026-07-01 | 2026-07-09 |
| HOPE-07-MIBC: Disitamab Vedotin Plus Immunotherapy vs Chemoimmunotherapy in Resectable HER2-Expressing MIBC Disitamab Vedotin (RC48), Gemcitabine + Cisplatin（GC）+Toripalimab, Toripalimab (JS001 ) - Urinary Bladder Neoplasms | Phase 2 / Phase 3 | Not yet recruiting | West China Hospital | 240 | 2026-06-20 | 2026-05-27 |
| Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma Disitamab Vedotin (RC48), radiotherapy, Gemcitabine (1000 mg/m2) - Upper Tract Urothelial Carcinoma | Phase 3 | Recruiting | Peking University First Hospital | 192 | 2026-05-01 | 2026-09-28 |
| Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study Disitamab Vedotin (RC48), Abiraterone + prednisone - mCRPC | Phase 2 | Recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | 20 | 2025-07-20 | 2025-07-30 |
| Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment RC48 + Carboplatin - Ovarian Cancer, HER2 | Phase 2 | Recruiting | Zhejiang Cancer Hospital | 20 | 2025-01-04 | 2025-12-16 |
| Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer SHR-A1811, SHR-A1921, SHR-A2009 - Advanced Breast Cancer, Metastatic Breast Cancer | Phase 2 | Recruiting | Fudan University | 160 | 2024-10-21 | 2026-09-03 |
| A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors disitamab vedotin, tucatinib - Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma | Phase 2 | Active not recruiting | Seagen, a wholly owned subsidiary of Pfizer | 54 | 2024-05-20 | 2026-07-22 |
| RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study Disitamab Vedotin (RC48), Bevacizumab, Pyrotinib - HER2 + Breast Cancer | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 74 | 2024-01-01 | 2025-07-15 |
| Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study Disitamab Vedotin (RC48), Bevacizumab - HER2-low Breast Cancer | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 37 | 2024-01-01 | 2026-03-03 |
| A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 disitamab vedotin - Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms | Phase 2 | Active not recruiting | Seagen, a wholly owned subsidiary of Pfizer | 120 | 2023-11-14 | 2026-07-22 |
| Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 disitamab vedotin, pembrolizumab, gemcitabine - Urothelial Carcinoma | Phase 3 | Active not recruiting | Seagen, a wholly owned subsidiary of Pfizer | 412 | 2023-09-22 | 2026-07-22 |
| Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial disitamab vedotin, Pyrotinib, trastuzumab - HER2-positive Metastatic Breast Cancer, First-line Treatment | Phase 3 | Recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 312 | 2023-09-06 | 2024-02-26 |
| RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer RC48 + Tislelizumab - Cervical Cancer Recurrent | Phase 2 | Unknown | Peking Union Medical College Hospital | 30 | 2023-08-16 | 2023-10-02 |
| RC48 Combined With Toripalimab and Radiotherapy for Bladder Sparing Treatment in MIBC Disitamab Vedotin and Toripalimab - Muscle Invasive Bladder Cancer, HER2 Expression | Phase 2 | Unknown | RenJi Hospital | 6 | 2023-08-01 | 2023-08-31 |
| Vedicitumomab Alone or in Combination for the Treatment of Locally Advanced or Metastatic SDC vedicitumomab (Edisil, RC48）, vedicitumomab in combination with pyrrolizidine, RC48 in combination with a platinum-based chemotherapeutic agent - Salivary Gland Cancer | Phase 1 / Phase 2 | Unknown | Peking Union Medical College | 120 | 2023-06-07 | 2023-06-12 |
| A Phase II Clinical Study of Fruquintinib Combined With RC48 in the Treatment of Previously Treated HER2-positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Cancer Fruquintinib + RC48 - Gastric Cancer | Phase 2 | Unknown | The First Affiliated Hospital of Zhengzhou University | 56 | 2022-05-07 | 2022-02-16 |
Breast Neoplasms (3) · Urinary Bladder Neoplasms (3) · Ovarian Neoplasms (2) · Stomach Neoplasms (2) · Triple Negative Breast Neoplasms (2) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Transitional Cell (1) · Endometrial Neoplasms (1) · Head and Neck Neoplasms (1) · Salivary Gland Neoplasms (1)
Seagen, a wholly owned subsidiary of Pfizer (3) · The First Affiliated Hospital with Nanjing Medical University (2) · Fudan University (1) · Peking Union Medical College (1) · Peking Union Medical College Hospital (1) · Peking University First Hospital (1) · RenJi Hospital (1) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (1) · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (1) · The First Affiliated Hospital of Zhengzhou University (1) · Tianjin Medical University Second Hospital (1) · West China Hospital (1) · Zhejiang Cancer Hospital (1) · Zhiquan Hu (1)
China (12) · Australia (3) · Canada (3) · Italy (3) · South Korea (3) · Spain (3) · United Kingdom (3) · United States (3) · Japan (2) · Taiwan (2) · Argentina (1) · Belgium (1) · Brazil (1) · Chile (1) · Czechia (1)
Feng Wang (1) · Haige Chen (1) · Lei Li, PhD (1) · Zhimin Shao, M.D. (1)
PMID 33109737, PMID 40774226, PMID 41193372
2023 (2)