13 not yet recruiting, 8 recruiting, 1 active not recruiting. 18 Phase 2, 2 Phase 4, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 18 | Not yet recruiting 11, Recruiting 7 |
| Phase 4 | 2 | Not yet recruiting 1, Recruiting 1 |
| Phase 3 | 1 | Not yet recruiting 1 |
Follow Trastuzumab Rezetecan: new trials by email Literature Review of Trastuzumab Rezetecan trials Research Report on Trastuzumab Rezetecan
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 |
|---|---|---|---|---|---|---|
| An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab in First to Third Line BLIS Subtype TNBC SHR- A1811, SHR-A1811+BEV - Breast Cancer, Triple Negative Breast Cancer (TNBC) | Phase 3 | Not yet recruiting | Fudan University | 140 | 2026-10-01 | 2026-06-25 |
| Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer Trastuzumab Rezetecan, Pyrotinib, trastuzumab - HER2 + Breast Cancer, Advanced Breast Cancer | Phase 2 | Not yet recruiting | Fujian Cancer Hospital | 50 | 2026-09-30 | 2026-08-14 |
| First-line Therapy With Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor(EGFR-TKI) Combined With Trastuzumab Rezetecan for Advanced Non-small Cell Lung Cancer(NSCLC) Harboring EGFR Mutations Concomitant With Human Epidermal Growth Factor Receptor 2(HER2) Alterations Almonertinib, Trastuzumab Rezetecan - Lung Cancer (NSCLC), EGFR Activating Mutation | Phase 2 | Not yet recruiting | Yongsheng Wang | 35 | 2026-09-09 | 2026-08-17 |
| Response-Guided Bladder Preservation With Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy in HER2-Expressing Muscle-Invasive Bladder Cancer Trastuzumab Rezetecan, Adebrelimab, Concurrent Bladder Radiotherapy - Muscle-Invasive Bladder Cancer (MIBC) | Phase 2 | Not yet recruiting | Tongji Hospital | 70 | 2026-09-01 | 2026-10-08 |
| A Prospective Phase II Clinical Trial Evaluating the Efficacy and Safety of Adebrelimab in Combination With Trastuzumab Rezetecan for Patients With Stage III Unresectable HER2-Positive NSCLC Adebrelimab, Trastuzumab rezetecan - NSCLC | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 37 | 2026-08-20 | 2026-08-21 |
| Neoadjuvant Gemcitabine Plus Trastuzumab Rezetecan in HER2-positive UTUC Trastuzumab Rezetecan, Gemcitabine, Radical nephroureterectomy - UTUC | Phase 2 | Recruiting | Zhiquan Hu | 54 | 2026-08-15 | 2026-08-03 |
| Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer Pyrotinib, Trastuzumab Rezetecan - HER2 + Breast Cancer, Advanced Breast Cancer | Phase 4 | Recruiting | Peking University People's Hospital | 500 | 2026-07-06 | 2026-07-13 |
| Trastuzumab Rezetecan(SHR-A1811) Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring HER2 Gene Abnormalities Trastuzumab Rezetecan, ivonescimab - Non Small Cell Lung Cancer | Phase 2 | Not yet recruiting | Sun Yat-sen University | 30 | 2026-07-01 | 2026-06-05 |
| Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor Trastuzumab Rezetecan - Solid Tumors, Neoplasms (Cancer / Tumors) | Phase 2 | Not yet recruiting | Haihua Yuan | 15 | 2026-06-15 | 2026-06-08 |
| Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer Trastuzumab Rezetecan for Injection (SHR-A1811), Trastuzumab Deruxtecan for Injection (T-DXd) - Advanced Breast Cancer | Phase 2 | Not yet recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 100 | 2026-06-01 | 2026-06-05 |
| Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP Trastuzumab Rezetecan - Breast Cancer, HER2-positive Breast Cancer | Phase 4 | Not yet recruiting | The First Affiliated Hospital with Nanjing Medical University | 59 | 2026-05-31 | 2026-05-15 |
| Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer Trastuzumab Rezetecan, Adebrelimab, Lenvatinib - Biliary Tract Neoplasms Immunotherapy | Phase 2 | Recruiting | Peking Union Medical College Hospital | 70 | 2026-04-29 | 2026-06-26 |
| Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib in Advanced HER2-Positive/Low-Expression Biliary Tract Cancer Trastuzumab Rezetecan, Adebrelimab, Lenvatinib - Biliary Tract Neoplasms Immunotherapy | Phase 2 | Recruiting | Peking Union Medical College Hospital | 70 | 2026-04-15 | 2026-07-15 |
| The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis Trastuzumab Rezetecan, Chemotherapy of Physician's Choice - HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis | Phase 2 | Recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 184 | 2026-03-01 | 2026-10-15 |
| Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer Trastuzumab rezetecan, Trastuzumab deruxtecan - Breast Cancer | Phase 2 | Not yet recruiting | Henan Cancer Hospital | 68 | 2026-03-01 | 2026-02-18 |
| Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer SHR-A1811, Adebrelimab (PD-L1 inhibitor), Taxane Chemotherapy - Breast Cancer Early Stage Breast Cancer (Stage 1-3), HR Positive/HER2 Low Breast Cancer | Phase 2 | Not yet recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 249 | 2026-02-15 | 2026-01-05 |
| Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies SHR-A1811, Trastuzumab Rezetecan - Urachal Cancer, Advanced Solid Tumor Cancer | Phase 2 | Recruiting | Sheng Zhang | 90 | 2025-12-18 | 2025-12-30 |
| Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) Adebrelimab, Trastuzumab Rezetecan - Urothelial Carcinoma, Advanced Urothelial Carcinoma | Phase 2 | Recruiting | Sun Yat-sen University | 96 | 2025-11-20 | 2026-04-30 |
| Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study Trastuzumab rezetecan, Pyrotinib, Dalpiciclib - HER2-positive Breast Cancer | Phase 2 | Not yet recruiting | Fudan University | 288 | 2025-09-10 | 2025-09-18 |
| Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases Trastuzumab Rezetecan, FSRT or WBRT - HER2-positive Advanced Breast Cancer, Brain Metastases | Phase 2 | Recruiting | Henan Cancer Hospital | 224 | 2025-08-30 | 2026-10-13 |
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Breast Neoplasms (7) · Biliary Tract Neoplasms (3) · Carcinoma, Non-Small-Cell Lung (3) · Carcinoma, Transitional Cell (2) · Brain Neoplasms (1) · Colorectal Neoplasms (1) · Endometrial Neoplasms (1) · Head and Neck Neoplasms (1) · Lung Neoplasms (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Paget Disease, Extramammary (1) · Pancreatic Neoplasms (1) · Recurrence (1) · Stomach Neoplasms (1)
Henan Cancer Hospital (3) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (2) · Fudan University (2) · Peking Union Medical College Hospital (2) · Sun Yat-sen University (2) · Fujian Cancer Hospital (1) · Haihua Yuan (1) · Lixiaoling (1) · Peking University People's Hospital (1) · Sheng Zhang (1) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (1) · The First Affiliated Hospital with Nanjing Medical University (1) · Tianjin Medical University Cancer Institute and Hospital (1) · Tongji Hospital (1) · Yongsheng Wang (1)
China (15)
Shaogang Wang (1) · Yanxia Shi, Doctor (1)