20 not yet recruiting, 17 recruiting, 6 active not recruiting, 5 unknown. 37 Phase 2, 10 Phase 1, 9 Phase 3, 1 Not applicable, 1 Phase 4.
Follow SHR-A1811: new trials by email Literature Review of SHR-A1811 trials Research Report on SHR-A1811
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 |
|---|---|---|---|---|---|---|
| SHR-A1811 Versus Trastuzumab Plus Pertuzumab in ctDNA-Positive HER2-Positive Early Breast Cancer After Pathologic Complete Response SHR-A1811, Trastuzumab, Pertuzumab - HER2-positive Breast Cancer, Early Breast Cancer (EBC) | Phase 2 | Not yet recruiting | Fudan University | 358 | 2026-10-01 | 2026-10-02 |
| SHR-A1811 Monotherapy or Sequential THPy as Neoadjuvant Therapy for Stage II-III HER2-Positive Breast Cancer SHR-A1811, THPy - HER2-positive Breast Cancer | Phase 2 | Not yet recruiting | First Affiliated Hospital of Zhejiang University | 80 | 2026-09-01 | 2026-08-26 |
| Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients SHR-A1811 - HER2positive, Advanced Breast Cancer | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 60 | 2026-06-10 | 2026-06-11 |
| 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 |
| Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+/HER2-Low Breast Cancer Dalpiciclib 125mg, Aromatase Inhibitor, SHR-A1811 - Breast Cancer, HR Positive/HER2 Low Breast Cancer | Phase 2 | Not yet recruiting | Tang-Du Hospital | 20 | 2026-06-01 | 2026-06-11 |
| 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 |
| Neoadjuvant SHR-A1811 Combined With Pertuzumab in HER2-Positive Breast Cancer: An Exploratory Clinical Study. SHR-A1811, Pertuzumab, trastuzumab - Breast Cancer | Phase 2 | Not yet recruiting | Hebei Medical University Fourth Hospital | 100 | 2026-05-01 | 2026-04-14 |
| SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study SHR-A1811, Pyrotinib, Capecitabine - Breast Cancer, HER2-positive Breast Cancer | Phase 2 | Not yet recruiting | Peking University Cancer Hospital & Institute | 100 | 2026-03-31 | 2026-02-18 |
| Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer Serplulimab, SHR-A1811 - Breast Cancer, Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer | Phase 2 | Not yet recruiting | Xijing Hospital | 84 | 2026-03-25 | 2026-03-12 |
| Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases SHR-A1811, SKB264, Pembrolizumab - HER2-negative Breast Cancer | Phase 2 | Not yet recruiting | Fudan University | 30 | 2026-03-15 | 2026-03-12 |
| Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype SHR-A1811, Famitinib+SHR-A1811 - Breast Cancer | Phase 3 | Not yet recruiting | Fudan University | 248 | 2026-02-26 | 2026-02-03 |
| 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 |
| Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC SHR-A1811 - Non-Small Cell Lung Cancer | Not applicable | Not yet recruiting | The First Affiliated Hospital of Guangzhou Medical University | 60 | 2026-02-15 | 2026-01-30 |
| Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer Nab paclitaxel, Carboplatin, Trastuzumab - HER2-positive Early Breast Cancer | Phase 2 | Recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 200 | 2025-12-25 | 2026-01-21 |
| 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 |
| Clinical Study of SHR-A1811 With or Without Letrozole in Neoadjuvant Therapy for Early-Stage HR-Positive, HER2-Low Breast Cancer SHR-A1811, Letrozole, TAC/AC-T - Breast Cancer | Phase 2 | Not yet recruiting | First Hospital of China Medical University | 120 | 2025-12-01 | 2025-12-26 |
| SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response SHR-A1811 - Early Breast Cancer, HER2 + Breast Cancer | Phase 2 | Not yet recruiting | Chuan Wang | 30 | 2025-10-01 | 2025-08-26 |
| A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases SHR-A1811, radiotherapy - Breast Cancer, Brain Metastases | Phase 1 / Phase 2 | Not yet recruiting | Peking University Cancer Hospital & Institute | 51 | 2025-09-30 | 2025-09-17 |
| 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 |
| SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer SHR-A1811, Carboplatin, Oxaliplatin - Ovarian Cancer | Phase 1 / Phase 2 | Not yet recruiting | Tongji Hospital | 90 | 2025-06-01 | 2025-05-25 |
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Breast Neoplasms (18) · Ovarian Neoplasms (4) · Triple Negative Breast Neoplasms (4) · Pathologic Complete Response (2) · Stomach Neoplasms (2) · Biliary Tract Neoplasms (1) · Brain Neoplasms (1) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Meningeal Carcinomatosis (1) · Neoplasm, Residual (1) · Paget Disease, Extramammary (1) · Recurrence (1) · Urachal cancer (1) · Uterine Cervical Neoplasms (1)
Fudan University (11) · Jiangsu HengRui Medicine Co., Ltd. (11) · Suzhou Suncadia Biopharmaceuticals Co., Ltd. (6) · Henan Cancer Hospital (2) · Peking University Cancer Hospital & Institute (2) · Tongji Hospital (2) · Beijing GoBroad Hospital (1) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (1) · China Medical University, China (1) · Chuan Wang (1) · First Affiliated Hospital of Zhejiang University (1) · First Hospital of China Medical University (1) · Hebei Medical University Fourth Hospital (1) · Huihua Xiong (1) · Second Affiliated Hospital, Zhejiang University, School of Medicine (1)
China (42) · Australia (1) · South Korea (1) · Taiwan (1) · United States (1)
Qinglei Gao (2) · Zhimin Shao, Professor (2) · Bin Shao (1) · Biyun Wang, Chief physician (1) · Caigang Liu, MD (1) · Dongmei Ji, Doctor (1) · Hanfang Jiang (1) · Hongxia Wang, Chief physician (1) · Wei Zhao (1) · Xiaoyan Li (1) · Zhenzhen Liu (1) · Zhimin Shao, M.D. (1)
PMID 38362377, PMID 38900984, PMID 39004647, PMID 40020696, PMID 40563015, PMID 41779980, PMID 42129335, PMID 42385760, PMID 42579830