Trastuzumab deruxtecan is currently evaluated in numerous clinical trials spanning Early Phase 1 to Phase 4 studies. These investigations primarily target HER2-positive, HER2-low, and metastatic breast cancers, alongside gastroesophageal adenocarcinomas and various advanced solid tumors. Sponsored by pharmaceutical entities such as Daiichi Sankyo and AstraZeneca alongside academic institutions like Fudan University and Washington University School of Medicine, these global trials encompass active, completed, and upcoming recruitment statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07553390 | NOT_YET_RECRUITING | Breast Cancer |
M.D. Anderson Cancer Center |
2026-10-01 | PHASE1 |
| NCT07060807 | RECRUITING | Breast Neoplasms |
Merck Sharp & Dohme LLC |
2025-07-21 | PHASE3 |
| NCT07578116 | NOT_YET_RECRUITING | Anatomic Stage IV Breast Cancer AJCC v8; Metastatic HER2-Positive Breast Carcinoma; Oligometastatic Breast Carcinoma |
SWOG Cancer Research Network |
2027-03-09 | PHASE3 |
| NCT06643585 | RECRUITING | Breast Cancer |
Prof. Wolfgang Janni |
2025-04-22 | PHASE3 |
| NCT07022483 | RECRUITING | Endometrial Cancer |
Daiichi Sankyo |
2025-09-30 | PHASE3 |
| NCT07630103 | NOT_YET_RECRUITING | Advanced Breast Cancer |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2026-06 | PHASE2 |
| NCT07701941 | NOT_YET_RECRUITING | Hormone Receptor Positive; HER2-low or HER2-ultralow; Unresectable or Metastatic Breast Cancer |
Daiichi Sankyo |
2026-08-03 | PHASE1; PHASE2 |
| NCT05633979 | ACTIVE_NOT_RECRUITING | Breast Cancer |
M.D. Anderson Cancer Center |
2023-02-09 | PHASE1 |
| NCT05868226 | RECRUITING | HER2-positive Breast Cancer; Metastatic Cancer; Metastatic Breast Cancer; Metastatic; HER2-positive Metastatic Breast Cancer; HER2 Mutation-Related Tumors; HER-2 Protein Overexpression; HER2-negative Breast Cancer; Triple Negative Breast Cancer; HR Positive; Hormone Receptor-positive Breast Cancer; Estrogen Receptor Positive Tumor; Progesterone Receptor-positive Breast Cancer; Hormone Receptor Negative Breast Carcinoma; Solid Tumor; Solid Tumor, Adult; Solid Carcinoma; HER2 Low Breast Cancer; HER2 Low Breast Carcinoma; ER Positive Breast Cancer; PR-positive Breast Cancer; Minimal Residual Disease; Colo-rectal Cancer; Colon Cancer; Rectal Cancer; ctDNA Monitoring; Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Neoplasm, Residual; Adenocarcinoma of Colon; Adenocarcinoma |
QuantumLeap Healthcare Collaborative |
2023-02-15 | PHASE1; PHASE2 |
| NCT01042379 | RECRUITING | Breast Neoplasms; Breast Cancer; Breast Tumors; Angiosarcoma; TNBC - Triple-Negative Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer |
QuantumLeap Healthcare Collaborative |
2010-03-01 | PHASE2 |
| NCT03424005 | RECRUITING | Metastatic Breast Cancer |
Hoffmann-La Roche |
2018-03-30 | PHASE1; PHASE2 |
| NCT07619365 | NOT_YET_RECRUITING | Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer |
Washington University School of Medicine |
2026-08-31 | PHASE2 |
| NCT07683754 | NOT_YET_RECRUITING | Advanced Breast Cancer; Metastatic Breast Cancer; HER2 Positive; HR Positive |
Daiichi Sankyo |
2026-09-04 | PHASE3 |
| NCT05704829 | RECRUITING | HER2-positive Early Breast Cancer |
Women's Cancer Study Group GmbH |
2024-02-05 | PHASE2 |
| NCT05765851 | RECRUITING | Advanced Solid Tumor |
Daiichi Sankyo |
2023-05-30 | PHASE1 |
| NCT06899126 | RECRUITING | Non-small Cell Lung Cancer |
Daiichi Sankyo |
2025-10-24 | PHASE3 |
| NCT06439693 | RECRUITING | Breast Cancer Female; Breast Cancer; Breast Cancer Metastatic; Estrogen Receptor-positive Breast Cancer; HER2-positive Breast Cancer; Stage IV Breast Cancer |
Dana-Farber Cancer Institute |
2024-08-08 | PHASE2 |
| NCT07459673 | RECRUITING | Breast Cancer; HER2-positive Breast Cancer; Breast Cancer Stage IV |
Memorial Sloan Kettering Cancer Center |
2026-03-04 | PHASE2 |
| NCT07195344 | RECRUITING | Locally Advanced or Metastatic Breast Cancers |
Institut Claudius Regaud |
2025-10-15 | PHASE4 |
| NCT07151586 | NOT_YET_RECRUITING | Triple Negative Breast Neoplasms; Neoplasm Metastasis; HER 2 Low-expressing Breast Cancer |
UNICANCER |
2026-09 | PHASE2 |
| NCT07371585 | RECRUITING | Breast Cancer Stage IV |
SOLTI Breast Cancer Research Group |
2026-02-18 | PHASE2 |
| NCT07782086 | NOT_YET_RECRUITING | Breast Cancer |
Shuangyue Liu |
2026-09-07 | |
| NCT07691489 | NOT_YET_RECRUITING | Colorectal Cancer; Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum |
Memorial Sloan Kettering Cancer Center |
2026-08 | PHASE2 |
| NCT06764875 | RECRUITING | HER2-positive Gastric Cancer; Gastroesophageal Junction Adenocarcinoma |
AstraZeneca |
2025-03-01 | PHASE3 |
| NCT07543536 | RECRUITING | Advanced/Metastatic Breast Cancer; HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer |
Sun Yat-sen University |
2026-06-08 | PHASE3 |
| NCT07417241 | NOT_YET_RECRUITING | Breast Cancer; HER2-positive Breast Cancer |
Peking University Cancer Hospital & Institute |
2026-03-31 | PHASE2 |
| NCT06989112 | RECRUITING | Endometrial Cancer |
AstraZeneca |
2025-03-27 | PHASE3 |
| NCT06324357 | RECRUITING | Metastatic Breast Cancer; Metastatic Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma; Colorectal Cancer |
Boehringer Ingelheim |
2024-06-28 | PHASE1; PHASE2 |
| NCT06750484 | RECRUITING | Breast Cancer Metastatic |
Yale University |
2025-06-20 | PHASE2 |
| NCT07015697 | RECRUITING | Recurrent or Metastatic Solid Tumors |
Daiichi Sankyo |
2025-07-17 | PHASE1 |
| NCT07130344 | NOT_YET_RECRUITING | Metastatic Breast Cancer; HER 2 Low-expressing Breast Cancer |
Centre Paul Strauss |
2025-09 | |
| NCT07785856 | NOT_YET_RECRUITING | T-dxd Resistant HER2-Positive; HER2 Low Metastatic Breast Cancer |
The Methodist Hospital Research Institute |
2026-12 | PHASE1; PHASE2 |
| NCT06819007 | RECRUITING | Ovarian Cancer |
Daiichi Sankyo |
2025-03-19 | PHASE3 |
| NCT07126561 | NOT_YET_RECRUITING | HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer Patients With an ECOG Performance Status of 2 |
University of Chicago |
2026-11-01 | PHASE2 |
| NCT06244485 | ACTIVE_NOT_RECRUITING | Advanced Solid Tumor |
Daiichi Sankyo |
2024-02-16 | PHASE1 |
| NCT06630130 | RECRUITING | Stomach Neoplasms |
Jeeyun Lee |
2025-01-22 | PHASE2 |
| NCT07182721 | RECRUITING | HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer; SKB264; Inetetamab |
Fudan University |
2025-09-30 | PHASE2 |
| NCT06680596 | ENROLLING_BY_INVITATION | Breast Cancer Metastatic; Breast Cancer Stage IV |
UNICANCER |
2025-07-30 | PHASE2 |
| NCT05408845 | RECRUITING | Metastatic Salivary Gland Carcinoma; Recurrent Salivary Gland Carcinoma; Stage III Major Salivary Gland Cancer AJCC v8; Stage IV Major Salivary Gland Cancer AJCC v8; Unresectable Salivary Gland Carcinoma |
NRG Oncology |
2023-03-03 | PHASE2 |
| NCT05372614 | RECRUITING | Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Malignant Solid Neoplasm; Unresectable Pancreatic Adenocarcinoma |
National Cancer Institute (NCI) |
2022-10-05 | PHASE1 |
| NCT06145308 | RECRUITING | Salivary Gland Carcinoma; Precision Therapy |
Peking Union Medical College |
2023-08-15 | PHASE2 |
| NCT07454668 | NOT_YET_RECRUITING | Breast Cancer; HER2-positive Breast Cancer; Brain Metastases; Cancer; Cancer Metastatic |
Baptist Health South Florida |
2026-06 | PHASE1 |
| NCT06467357 | RECRUITING | Biliary Tract Cancer |
AstraZeneca |
2024-08-12 | PHASE3 |
| NCT04986579 | RECRUITING | Metastatic Breast Cancer; Chemotherapy-induced Alopecia |
Dana-Farber Cancer Institute |
2021-10-07 | PHASE2 |
| NCT06731478 | RECRUITING | Gastric Cancer; Gastroesophageal Junction Cancer |
Daiichi Sankyo |
2025-02-27 | PHASE3 |
| NCT07198724 | RECRUITING | Metastatic Breast Cancer; HER2 Low Breast Carcinoma; HER2-negative Breast Cancer; Breast Cancer; Breast Cancer Female |
Kristina A. Fanucci |
2025-11-17 | PHASE1; PHASE2 |
| NCT07497386 | RECRUITING | Unresectable Locally Recurrent Breast Cancer; Unresectable Locally Metastatic Breast Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2026-04-28 | PHASE2 |
| NCT06263543 | RECRUITING | Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Hormone-receptor-positive Breast Cancer; Human Epidermal Growth Factor 2 Low Breast Cancer |
Reshma L. Mahtani, D.O. |
2024-06-17 | PHASE2 |
| NCT06435429 | RECRUITING | Metastatic HER2-positive Breast Cancer |
Jazz Pharmaceuticals |
2024-08-13 | PHASE3 |
| NCT05034887 | ACTIVE_NOT_RECRUITING | Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma |
National Cancer Center Hospital East |
2022-01-31 | PHASE2 |
| NCT06311214 | RECRUITING | Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2025-03-18 | PHASE2 |
| NCT07465172 | NOT_YET_RECRUITING | Breast Cancer |
Breast Cancer Trials, Australia and New Zealand |
2026-03 | |
| NCT05417594 | RECRUITING | Advanced Solid Malignancies |
AstraZeneca |
2022-06-24 | PHASE1; PHASE2 |
| NCT07294508 | RECRUITING | HER2 + Breast Cancer |
Shanghai Henlius Biotech |
2026-02-27 | PHASE2; PHASE3 |
| NCT07137416 | RECRUITING | Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Invasive Breast Carcinoma; Locally Advanced Breast Carcinoma; Metastatic Breast Carcinoma; Metastatic HER2-Low Breast Carcinoma; Metastatic HER2-Positive Breast Carcinoma; Metastatic Hormone Receptor-Positive Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Triple-Negative Breast Carcinoma; Unresectable Breast Carcinoma; Unresectable HER2-Low Breast Carcinoma; Unresectable HER2-Positive Breast Carcinoma; Unresectable Hormone Receptor-Positive Breast Carcinoma; Unresectable Malignant Solid Neoplasm; Unresectable Triple-Negative Breast Carcinoma |
National Cancer Institute (NCI) |
2026-10-05 | PHASE1 |
| NCT06533826 | RECRUITING | Breast Cancer; HER2-low Breast Cancer; Metastatic Breast Cancer; HER2-negative Breast Cancer |
Ana C Garrido-Castro, MD |
2024-10-29 | PHASE2 |
| NCT06733233 | NOT_YET_RECRUITING | Breast Cancer, Estrogen Receptor-Positive; HER2 Low Breast Cancer |
Guangzhou Women and Children's Medical Center |
2025-01-01 | PHASE2 |
| NCT06771622 | ACTIVE_NOT_RECRUITING | Solid Cancer |
FBD Biologics Limited |
2025-03-13 | PHASE1; PHASE2 |
| NCT06731803 | ACTIVE_NOT_RECRUITING | Esophagogastric Adenocarcinoma |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
2025-03-25 | PHASE1; PHASE2 |
| NCT07662473 | NOT_YET_RECRUITING | NSCLC |
Hunan Province Tumor Hospital |
2026-07-29 | PHASE2 |
| NCT02693535 | RECRUITING | Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors |
American Society of Clinical Oncology |
2016-03-14 | PHASE2 |
| NCT07162259 | NOT_YET_RECRUITING | Breast Neoplasms |
Yan Xue |
2025-10-01 | PHASE4 |
| NCT04616560 | RECRUITING | Desmoplastic Small Round Cell Tumor; Osteosarcoma; Recurrent Desmoplastic Small Round Cell Tumor; Recurrent Kidney Wilms Tumor; Recurrent Osteosarcoma; Refractory Desmoplastic Small Round Cell Tumor; Refractory Wilms Tumor; Wilms Tumor |
National Cancer Institute (NCI) |
2021-03-08 | PHASE2 |
| NCT07647016 | RECRUITING | Breast Cancer |
Fudan University |
2026-04-01 | PHASE2 |
| NCT05795101 | RECRUITING | Invasive Breast Cancer; Inflammatory Breast Cancer Stage III; HER2-positive Breast Cancer; HER2 Low Breast Adenocarcinoma; Breast Cancer |
Filipa Lynce, MD |
2023-05-04 | PHASE2 |
| NCT07333937 | NOT_YET_RECRUITING | Brest Cancer |
Xijing Hospital |
2025-12-20 | PHASE2 |
| NCT07318389 | NOT_YET_RECRUITING | Dynamic Tumor Resistance; Metastatic Colorectal Cancer |
M.D. Anderson Cancer Center |
2026-06-10 | EARLY_PHASE1 |
| NCT07069712 | RECRUITING | Gastroesophageal Adenocarcinoma |
AstraZeneca |
2025-07-17 | PHASE2 |
| NCT07152782 | NOT_YET_RECRUITING | Breast Cancer With Brain Metastasis; HER2-positive Breast Cancer |
Fudan University |
2025-11 | PHASE2 |
| NCT07407465 | RECRUITING | Colorectal Cancer; Colorectal Adenocarcinoma; Rectal Adenocarcinoma; Rectal Cancer, Adenocarcinoma; Rectal Cancer, Metastatic; Colon Cancer Metastatic; Colon Cancer Adenocarcinoma |
Gruppo Oncologico del Nord-Ovest |
2025-10-20 | PHASE2 |
| NCT05950945 | RECRUITING | Breast Cancer |
Daiichi Sankyo |
2023-12-30 | PHASE3 |
| NCT05982678 | RECRUITING | HER2-positive Breast Cancer |
The Netherlands Cancer Institute |
2024-05-02 | PHASE2 |
| NCT06610825 | RECRUITING | Prostate Cancer Metastatic; Prostate Cancer; CRPC |
Washington D.C. Veterans Affairs Medical Center |
2025-03-05 | PHASE2 |
| NCT07393425 | RECRUITING | HER2 + Breast Cancer |
Shanghai Jiao Tong University School of Medicine |
2026-02-02 | PHASE2 |
| NCT06058988 | RECRUITING | Brain Cancer; Glioblastoma; Metastatic Cancer; Leptomeningeal Metastasis; Recurrent Glioblastoma |
Memorial Sloan Kettering Cancer Center |
2023-09-22 | PHASE2 |
| NCT07150208 | NOT_YET_RECRUITING | Breast Cancer With Brain Metastasis; HER2-low Expressing Breast Cancer |
Fudan University |
2025-09 | PHASE2 |
| NCT06525298 | RECRUITING | Advanced Solid Tumor; Homologous Recombination Deficiency; HRR Deficiency |
Eisbach Bio GmbH |
2024-09-09 | PHASE1; PHASE2 |
| NCT06298084 | RECRUITING | Breast Cancer Metastatic; HER2-positive Metastatic Breast Cancer; HER2 Low Breast Carcinoma; Advanced Breast Cancer |
Gustave Roussy, Cancer Campus, Grand Paris |
2024-03-21 | PHASE1; PHASE2 |
| NCT05593094 | ACTIVE_NOT_RECRUITING | Advanced Solid Tumors; HER2-positive Breast Cancer |
Hoffmann-La Roche |
2020-09-03 | PHASE1; PHASE2 |
| NCT07086768 | RECRUITING | Solid Tumor; Advanced Solid Tumor; Metastatic Solid Tumor |
Lei Zheng |
2026-01-26 | PHASE1 |
| NCT06364410 | RECRUITING | Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Locally Advanced Gastric Carcinoma; Locally Advanced Gastroesophageal Junction Adenocarcinoma; Locally Advanced Malignant Solid Neoplasm; Metastatic Gastric Carcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Metastatic Malignant Solid Neoplasm; Unresectable Gastric Carcinoma; Unresectable Gastroesophageal Junction Adenocarcinoma; Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2025-02-03 | PHASE1 |
| NCT04686305 | RECRUITING | Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
AstraZeneca |
2021-03-09 | PHASE1 |
| NCT06102824 | RECRUITING | HER2-negative Breast Cancer; Advanced Breast Cancer |
Guangdong Provincial People's Hospital |
2024-10-01 | PHASE2 |
| NCT07012031 | RECRUITING | Locally Advanced Lung Non-Small Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8 |
National Cancer Institute (NCI) |
2026-06-17 | PHASE1; PHASE2 |
| NCT07368543 | NOT_YET_RECRUITING | Metastatic Breast Cancer |
Fudan University |
2026-01-16 | PHASE2 |
| NCT06832202 | RECRUITING | HER2-low Hormone Receptor Positive Breast Cancer |
Shanghai Henlius Biotech |
2025-04-16 | PHASE2 |
| NCT05614739 | RECRUITING | Urinary Bladder Neoplasms; Neoplasm Metastasis; Ureteral Neoplasms |
Eli Lilly and Company |
2023-01-12 | PHASE1 |
| NCT04644068 | ACTIVE_NOT_RECRUITING | Ovarian Cancer; Breast Cancer; Pancreatic Cancer; Prostate Cancer; Additional Indications Below for Module 4 and 5; Non-small Cell Lung Cancer; Colorectal Cancer; Bladder Cancer; Gastric Cancer; Biliary Cancer; Cervical Cancer; Endometrial Cancer; Small Cell Lung Cancer Only in Module 5 |
AstraZeneca |
2020-11-12 | PHASE1; PHASE2 |
| NCT04379596 | ACTIVE_NOT_RECRUITING | Gastric Cancer |
AstraZeneca |
2020-06-03 | PHASE2 |
| NCT06665178 | RECRUITING | Breast Cancer |
British Columbia Cancer Agency |
2025-03-31 | PHASE2 |
| NCT05900206 | RECRUITING | Breast Cancer |
Karolinska University Hospital |
2023-10-26 | PHASE2 |
| NCT05376878 | RECRUITING | Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic Malignant Neoplasm in the Brain |
City of Hope Medical Center |
2022-12-21 | PHASE4 |
| NCT06172127 | ACTIVE_NOT_RECRUITING | HER2-positive Breast Cancer |
MedSIR |
2024-07-22 | PHASE2 |
| NCT06409390 | RECRUITING | Metastatic Breast Cancer |
H. Lee Moffitt Cancer Center and Research Institute |
2024-08-14 | PHASE2 |
| NCT04704661 | ACTIVE_NOT_RECRUITING | Advanced Breast Carcinoma; Advanced Colon Carcinoma; Advanced Colorectal Carcinoma; Advanced Endometrial Carcinoma; Advanced Gastric Carcinoma; Advanced Gastroesophageal Junction Adenocarcinoma; Advanced Malignant Solid Neoplasm; Advanced Salivary Gland Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; HER2-Positive Breast Carcinoma; Malignant Hepatobiliary Neoplasm; Metastatic Breast Carcinoma; Metastatic Colon Carcinoma; Metastatic Colorectal Carcinoma; Metastatic Endometrial Carcinoma; Metastatic Gastric Carcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Salivary Gland Carcinoma; Stage III Colon Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Major Salivary Gland Cancer AJCC v8; Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Major Salivary Gland Cancer AJCC v8; Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8; Unresectable Breast Carcinoma; Unresectable Colon Carcinoma; Unresectable Colorectal Carcinoma; Unresectable Endometrial Carcinoma; Unresectable Gastric Carcinoma; Unresectable Gastroesophageal Junction Adenocarcinoma; Unresectable Malignant Solid Neoplasm; Unresectable Salivary Gland Carcinoma |
National Cancer Institute (NCI) |
2021-08-09 | PHASE1 |
| NCT04482309 | ACTIVE_NOT_RECRUITING | Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer; Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer |
AstraZeneca |
2020-08-18 | PHASE2 |
| NCT06253650 | RECRUITING | Gastric Cancer; HER2-positive Gastric Cancer |
Gruppo Oncologico del Nord-Ovest |
2024-03-01 | PHASE2 |
| NCT07416253 | NOT_YET_RECRUITING | Breast Cancer |
Henan Cancer Hospital |
2026-03 | PHASE2 |
| NCT07428044 | RECRUITING | Non-Small Cell Lung Cancer; Non-small Cell Lung Cancer Stage II; Non-Small Cell Lung Cancer Stage IIIA; Non-Small Cell Lung Cancer Stage IIIB |
Memorial Sloan Kettering Cancer Center |
2026-02-13 | PHASE2 |
| NCT06271837 | ACTIVE_NOT_RECRUITING | Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer) |
AstraZeneca |
2024-02-22 | PHASE2 |
| NCT06797622 | NOT_YET_RECRUITING | Breast Cancer; Metastatic Breast Cancer |
Fudan University |
2025-02-15 | PHASE2 |
| NCT06486883 | RECRUITING | Advanced Breast Cancer; Advanced Breast Carcinoma; Hormone Receptor Positive Breast Carcinoma |
MedSIR |
2025-06-30 | PHASE2 |
| NCT06331169 | RECRUITING | Breast Cancer |
Fudan University |
2024-07-31 | PHASE1 |
| NCT04553770 | RECRUITING | Early-stage Breast Cancer; Hormone Receptor Positive Breast Carcinoma; Invasive Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer |
Jonsson Comprehensive Cancer Center |
2020-10-09 | PHASE2 |
| NCT07254416 | NOT_YET_RECRUITING | Breast Cancer Patients Treated With T-DXd |
Tianjin Medical University Cancer Institute and Hospital |
2025-12-15 | PHASE4 |
| NCT04585958 | RECRUITING | Metastatic Malignant Solid Neoplasm; Platinum-Resistant Ovarian High Grade Serous Adenocarcinoma; Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2021-05-21 | PHASE1 |
| NCT07340164 | RECRUITING | Ovarian Cancer; Ovarian Carcinoma, Recurrent; Ovarian Cancer Metastatic Recurrent; Ovarian Cancer (OvCa) |
Yonsei University |
2026-02-26 | PHASE2 |
| NCT07716189 | RECRUITING | Nausea and Vomiting Caused by Trastuzumab Deruxtecan |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2025-12-12 | PHASE3 |
| NCT07446452 | RECRUITING | HER2-low Breast Cancer |
The First Affiliated Hospital with Nanjing Medical University |
2024-01-01 | PHASE2 |
| NCT06250777 | ENROLLING_BY_INVITATION | Non Small Cell Lung Cancer |
Yonsei University |
2024-07-11 | PHASE2 |
| NCT04829604 | ACTIVE_NOT_RECRUITING | HER2 Positive Metastatic Breast Cancer |
Ambrx, Inc. |
2021-10-26 | PHASE2 |
| NCT04784715 | ACTIVE_NOT_RECRUITING | Breast Cancer; HER2-positive; Metastatic |
AstraZeneca |
2021-04-26 | PHASE3 |
| NCT06048718 | ACTIVE_NOT_RECRUITING | Breast Cancer; Metastatic Breast Cancer |
MedSIR |
2024-06-05 | PHASE2 |
| NCT07537673 | RECRUITING | Nausea and Vomiting Caused by Trastuzumab Deruxtecan |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2025-11-25 | PHASE2 |
| NCT06429761 | RECRUITING | BREAST CANCER |
AstraZeneca |
2025-01-02 | PHASE4 |
| NCT07619521 | NOT_YET_RECRUITING | Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma |
National Cancer Institute (NCI) |
2026-09-08 | PHASE1; PHASE2 |
| NCT06837792 | RECRUITING | Hormone Receptor(HR)-Positive, Low HER2 Advanced Breast Cancer Patients (HER2 IHC 1+ or 2+ & ISH Negative) |
Yonsei University |
2023-10-01 | PHASE2 |
| NCT06578286 | NOT_YET_RECRUITING | Breast Cancer |
Fudan University |
2024-09-30 | PHASE2 |
| NCT04704934 | ACTIVE_NOT_RECRUITING | Gastric Cancer, Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma |
Daiichi Sankyo |
2021-05-21 | PHASE3 |
| NCT07134153 | RECRUITING | Breast Cancer |
Fudan University |
2025-04-18 | PHASE1; PHASE2 |
| NCT06174987 | RECRUITING | Advanced Cancer; Metastatic Cancer |
Daiichi Sankyo |
2024-01-05 | PHASE3 |
| NCT07117864 | RECRUITING | Breast Cancer |
QIAO LI |
2025-07-01 | |
| NCT05650879 | ACTIVE_NOT_RECRUITING | HER2 Mutant Non-small Cell Lung Cancer; HER2-positive Metastatic Breast Cancer; HER2 Gene Mutation; HER2 Amplification |
Enliven Therapeutics |
2023-03-20 | PHASE1 |
| NCT05048797 | ACTIVE_NOT_RECRUITING | Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
AstraZeneca |
2021-10-28 | PHASE3 |
| NCT05274048 | RECRUITING | Gastric Cancer; Gastrointestinal Cancer; HER2 Gene Mutation |
Fox Chase Cancer Center |
2022-06-24 | PHASE1 |
| NCT07281001 | RECRUITING | HER2-positive Breast Cancer; Trastuzumab Deruxtecan |
Blokhin's Russian Cancer Research Center |
2025-12 | |
| NCT05845450 | RECRUITING | Colorectal Cancer; Resectable Colorectal Carcinoma |
Gruppo Oncologico del Nord-Ovest |
2023-05-11 | PHASE2 |
| NCT05965479 | RECRUITING | Gastrooesophageal Cancer |
University of Southampton |
2024-04-10 | PHASE2 |
| NCT06245824 | NOT_YET_RECRUITING | Breast Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2024-01-30 | PHASE4 |
| NCT06100874 | ACTIVE_NOT_RECRUITING | Her 2 Positive Breast Cancer; Breast Cancer Female; Breast Cancer Metastatic |
Adrienne G. Waks |
2023-11-20 | PHASE2 |
| NCT06328387 | UNKNOWN | Advanced Breast Cancer; Metastatic Breast Cancer |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2024-01-29 | PHASE1; PHASE2 |
| NCT06585969 | WITHDRAWN | Metastatic Breast Cancer; ER-positive Breast Cancer; Luminal B; Her2 Enriched; Basal Like |
Danish Breast Cancer Cooperative Group |
2026-01-01 | PHASE3 |
| NCT07529613 | COMPLETED | Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma |
National Cancer Center Hospital East |
2023-12-20 | PHASE1; PHASE2 |
| NCT07065435 | RECRUITING | HER2 + Breast Cancer |
The First Affiliated Hospital with Nanjing Medical University |
2024-01-01 | PHASE2 |
| NCT05894824 | RECRUITING | Gastric Cancer; Gastroesophageal Junction (GEJ) Cancer |
Yonsei University |
2024-02-05 | PHASE1; PHASE2 |
| NCT06085755 | RECRUITING | Stomach Neoplasm |
Jeeyun Lee |
2024-09-30 | PHASE1; PHASE2 |
| NCT05824975 | RECRUITING | Advanced Solid Tumor; Metastatic Solid Tumor; Soft Tissue Sarcoma (STS); Platinum-resistant Ovarian Cancer (PROC); Hepatocellular Carcinoma (HCC); Colorectal Cancer (CRC); HER2 Negative Breast Cancer; Cutaneous Melanoma; Renal Cell Carcinoma (RCC) |
GI Innovation, Inc. |
2023-05-30 | PHASE1; PHASE2 |
| NCT05710666 | ACTIVE_NOT_RECRUITING | HER2-positive Breast Cancer |
Cancer Trials Ireland |
2023-10-26 | PHASE2 |
| NCT04294628 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2020-09-01 | PHASE1 |
| NCT06548178 | NOT_YET_RECRUITING | HER2-positive Breast Cancer |
Fudan University |
2024-09 | PHASE2 |
| NCT04042701 | ACTIVE_NOT_RECRUITING | Breast Cancer; Non-small Cell Lung Carcinoma |
Daiichi Sankyo |
2020-02-10 | PHASE1 |
| NCT05744375 | TERMINATED | Locally Advanced Breast Cancer; Metastatic Breast Cancer |
Spanish Breast Cancer Research Group |
2023-09-28 | PHASE2 |
| NCT04622319 | ACTIVE_NOT_RECRUITING | HER2-Positive Primary Breast Cancer; Residual Invasive Breast Cancer |
Daiichi Sankyo |
2020-12-04 | PHASE3 |
| NCT04257162 | ACTIVE_NOT_RECRUITING | Metastatic Cancer |
SOLTI Breast Cancer Research Group |
2019-12-13 | |
| NCT05480384 | ACTIVE_NOT_RECRUITING | Esophageal Adenocarcinoma; Esophageal Cancer; HER-2 Protein Overexpression; Gastroesophageal-junction Cancer |
Brown University |
2023-07-14 | PHASE2 |
| NCT05113251 | ACTIVE_NOT_RECRUITING | Breast Neoplasms; Breast Cancer; HER2-positive Early Breast Cancer |
AstraZeneca |
2021-10-25 | PHASE3 |
| NCT04538742 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
AstraZeneca |
2020-12-28 | PHASE1; PHASE2 |
| NCT03742102 | ACTIVE_NOT_RECRUITING | Triple Negative Breast Neoplasms |
AstraZeneca |
2018-12-21 | PHASE1; PHASE2 |
| NCT05246514 | ACTIVE_NOT_RECRUITING | HER2-mutant Non-Small Cell Lung Cancer |
AstraZeneca |
2022-07-13 | PHASE2 |
| NCT05954143 | TERMINATED | Metastatic Breast Cancer; HER2-positive Breast Cancer |
Bolt Biotherapeutics, Inc. |
2023-11-30 | PHASE2 |
| NCT03334617 | ACTIVE_NOT_RECRUITING | Non-Small Cell Lung Cancer |
AstraZeneca |
2017-12-18 | PHASE2 |
| NCT05953168 | UNKNOWN | Triple-Negative Breast Cancer |
Fudan University |
2023-08 | PHASE2 |
| NCT04539938 | COMPLETED | HER2 Positive Breast Cancer |
Seagen, a wholly owned subsidiary of Pfizer |
2020-12-01 | PHASE2 |
| NCT05097599 | TERMINATED | Cancer; Advanced Solid Tumor |
Strata Oncology |
2022-04-29 | PHASE2 |
| NCT05919212 | UNKNOWN | Metastatic Breast Cancer |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
2023-02-01 | |
| NCT06088056 | UNKNOWN | Breast Cancer; Brain Metastases; Radiotherapy |
Fudan University |
2023-11 | PHASE2 |
| NCT06331169 | Not yet recruiting | Breast Cancer |
Fudan University |
2024-04-01 | Phase 1 |
| NCT05965479 | Recruiting | Gastrooesophageal Cancer |
University of Southampton|AstraZeneca|Natera Inc. |
2024-04-10 | Phase 2 |
| NCT04494425 | ACTIVE_NOT_RECRUITING | Advanced or Metastatic Breast Cancer |
AstraZeneca |
2020-07-24 | PHASE3 |
| NCT04739761 | ACTIVE_NOT_RECRUITING | Breast Cancer |
AstraZeneca |
2021-06-22 | PHASE3 |
| NCT06271837 | Recruiting | Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer) |
AstraZeneca|Daiichi Sankyo Co. Ltd. |
2024-02-18 | Phase 2 |
| NCT06210776 | Recruiting | HER2-positive Breast Cancer|HER2-low Breast Cancer|Breast Cancer|Advanced Cancer |
Daiichi Sankyo |
2024-01-15 | -- |
| NCT05458674 | Recruiting | Breast Cancer |
Criterium Inc. |
2024-01-01 | Phase 2 |
| NCT05993234 | Recruiting | HER2-positive Advanced Gastric Cancer|HER2-positive Gastroesophageal Junction Adenocarcinoma |
Daiichi Sankyo Europe GmbH a Daiichi Sankyo Company|Daiichi Sankyo |
2023-12-05 | -- |
| NCT04556773 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
AstraZeneca |
2020-12-17 | PHASE1 |
| NCT04989816 | COMPLETED | Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma |
AstraZeneca |
2021-08-20 | PHASE2 |
| NCT04752059 | COMPLETED | Breast Cancer Stage IV |
Medical University of Vienna |
2020-07-28 | PHASE2 |
| NCT04639219 | ACTIVE_NOT_RECRUITING | Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast |
AstraZeneca |
2020-12-30 | PHASE2 |
| NCT04644237 | COMPLETED | Non-Small Cell Lung Cancer |
Daiichi Sankyo |
2021-03-19 | PHASE2 |
| NCT04744831 | COMPLETED | Advanced Colorectal Cancer |
Daiichi Sankyo |
2021-03-05 | PHASE2 |
| NCT05091528 | TERMINATED | HER2-positive Breast Cancer; HER2-positive Gastric Cancer; HER2-positive Colorectal Cancer; HER2-expressing Non-small Cell Lung Cancer |
Silverback Therapeutics |
2022-02-08 | PHASE1; PHASE2 |
| NCT03523585 | COMPLETED | Breast Cancer |
Daiichi Sankyo |
2018-08-01 | PHASE3 |
| NCT03734029 | ACTIVE_NOT_RECRUITING | Breast Cancer |
Daiichi Sankyo |
2018-12-27 | PHASE3 |
| NCT04014075 | COMPLETED | Adenocarcinoma Gastric Stage IV With Metastases; Adenocarcinoma - GEJ |
Daiichi Sankyo |
2019-11-26 | PHASE2 |
| NCT04132960 | COMPLETED | Breast Tumors |
UNICANCER |
2019-10-21 | PHASE2 |
| NCT04420598 | COMPLETED | Advanced Breast Cancer; HER2-positive Breast Cancer; Brain Metastases; Leptomeningeal Metastasis |
MedSIR |
2020-05-25 | PHASE2 |
| NCT03523572 | COMPLETED | Breast Cancer; Urothelial Carcinoma |
Daiichi Sankyo |
2018-08-02 | PHASE1 |
| NCT03529110 | ACTIVE_NOT_RECRUITING | Breast Cancer |
Daiichi Sankyo |
2018-08-09 | PHASE3 |
| NCT03505710 | TERMINATED | Non-Small Cell Lung Cancer |
Daiichi Sankyo |
2018-05-21 | PHASE2 |
| NCT03329690 | COMPLETED | Neoplasm, Gastrointestinal |
Daiichi Sankyo Co., Ltd. |
2017-11-02 | PHASE2 |
| NCT03384940 | COMPLETED | Colorectal Neoplasm |
Daiichi Sankyo Co., Ltd. |
2018-02-23 | PHASE2 |
| NCT03248492 | TERMINATED | Breast Cancer |
Daiichi Sankyo |
2017-08-25 | PHASE2 |
| NCT02564900 | COMPLETED | Advanced Solid Tumors |
Daiichi Sankyo Co., Ltd. |
2015-09-01 | PHASE1 |
| NCT03366428 | COMPLETED | Malignant Neoplasm of Breast |
Daiichi Sankyo Co., Ltd. |
2017-12-26 | PHASE1 |
| NCT03383692 | COMPLETED | Neoplasm Metastasis |
Daiichi Sankyo Co., Ltd. |
2018-01-12 | PHASE1 |
| NCT03368196 | COMPLETED | Adenocarcinoma, Gastric; Neoplasm, Breast |
Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company |
2018-04-02 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-19)
Check the
Trastuzumab-deruxtecan (DS-8201a, T-DXd)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Trastuzumab-deruxtecan (DS-8201a, T-DXd) Stock Solution
- Trastuzumab-deruxtecan (DS-8201a, T-DXd) Storage
- Trastuzumab-deruxtecan (DS-8201a, T-DXd) Stability
- Trastuzumab-deruxtecan (DS-8201a, T-DXd) Molecular Weight
- Trastuzumab-deruxtecan (DS-8201a, T-DXd) CAS Number
- Trastuzumab-deruxtecan (DS-8201a, T-DXd) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.