Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 3 evaluate deruxtecan-containing antibody-drug conjugates across oncology indications, prominently including non-small cell lung cancer, metastatic breast cancer, esophageal adenocarcinoma, and urothelial carcinoma. Supported by pharmaceutical sponsors like AstraZeneca and Daiichi Sankyo as well as academic institutions such as Washington University School of Medicine and Fudan University, these studies range in recruitment status from active recruitment and enrollment by invitation to completion.

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
NCT07776691 NOT_YET_RECRUITING
Ovarian Cancer; Ovarian Neoplasms; Peritoneal Cancer; Fallopian Tube Cancer
Merck Sharp & Dohme LLC
2026-09-22 PHASE3
NCT06780085 RECRUITING
Carcinoma, Non-Small-Cell Lung
Merck Sharp & Dohme LLC
2025-05-13 PHASE2
NCT04165070 RECRUITING
Carcinoma, Non-Small-Cell Lung
Merck Sharp & Dohme LLC
2019-12-19 PHASE1; PHASE2
NCT07069595 RECRUITING
Breast Cancer; Residual Disease; Triple Negative Breast Cancer (TNBC); Stage II/III
UNC Lineberger Comprehensive Cancer Center
2026-02-26 PHASE2
NCT07743164 NOT_YET_RECRUITING
Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer
Merck Sharp & Dohme LLC
2026-10-05 PHASE3
NCT07630974 RECRUITING
Malignant Neoplasm
Merck Sharp & Dohme LLC
2026-07-06 PHASE1; PHASE2
NCT07630103 NOT_YET_RECRUITING
Advanced Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2026-06 PHASE2
NCT06863272 RECRUITING
Castration-Resistant Prostatic Cancer; Metastasis
Merck Sharp & Dohme LLC
2025-07-03 PHASE1; 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
NCT06941272 RECRUITING
Malignant Neoplasm
Merck Sharp & Dohme LLC
2025-05-26 PHASE1; PHASE2
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
NCT07227597 RECRUITING
Small Cell Lung Cancer Extensive Stage
Merck Sharp & Dohme LLC
2026-01-29 PHASE1; PHASE2
NCT03424005 RECRUITING
Metastatic Breast Cancer
Hoffmann-La Roche
2018-03-30 PHASE1; PHASE2
NCT07720284 RECRUITING
High-risk Muscle Invasive Urothelial Carcinoma
AstraZeneca
2026-07-16 PHASE3
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
NCT06899126 RECRUITING
Non-small Cell Lung Cancer
Daiichi Sankyo
2025-10-24 PHASE3
NCT06686394 RECRUITING
Breast Neoplasms; Breast Cancer
Merck Sharp & Dohme LLC
2025-02-26 PHASE1; PHASE2
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
NCT05215340 ACTIVE_NOT_RECRUITING
Metastatic Non Small Cell Lung Cancer
Daiichi Sankyo
2022-03-04 PHASE3
NCT07459673 RECRUITING
Breast Cancer; HER2-positive Breast Cancer; Breast Cancer Stage IV
Memorial Sloan Kettering Cancer Center
2026-03-04 PHASE2
NCT06797635 RECRUITING
Breast Neoplasms; Breast Cancer
Merck Sharp & Dohme LLC
2025-03-20 PHASE2
NCT06357533 RECRUITING
Non-Small Cell Lung Cancer
AstraZeneca
2024-04-11 PHASE3
NCT07151586 NOT_YET_RECRUITING
Triple Negative Breast Neoplasms; Neoplasm Metastasis; HER 2 Low-expressing Breast Cancer
UNICANCER
2026-09 PHASE2
NCT07195344 RECRUITING
Locally Advanced or Metastatic Breast Cancers
Institut Claudius Regaud
2025-10-15 PHASE4
NCT06469944 RECRUITING
Gastroesophageal Junction; Gastroesophageal Adenocarcinoma; Esophageal Neoplasms; Esophageal Cancer
Merck Sharp & Dohme LLC
2024-09-20 PHASE1; PHASE2
NCT07286149 RECRUITING
Lung Neoplasm Malignant
Merck Sharp & Dohme LLC
2026-04-30 PHASE1; PHASE2
NCT07738341 NOT_YET_RECRUITING
Breast Cancer (Locally Advanced or Metastatic)
Eddingpharm (Zhuhai) Co., Ltd.
2026-08-01 PHASE1; PHASE2
NCT07371585 RECRUITING
Breast Cancer Stage IV
SOLTI Breast Cancer Research Group
2026-02-18 PHASE2
NCT07791732 NOT_YET_RECRUITING
Fallopian Tube Cancer; Primary Peritoneal Cancer; High-Grade Serous Ovarian Cancer; Endometrioid Epithelial Ovarian
Daiichi Sankyo
2026-10-01 PHASE3
NCT07782086 NOT_YET_RECRUITING
Breast Cancer
Shuangyue Liu
2026-09-07
NCT07129993 RECRUITING
Urothelial Cancer; Bladder Cancer
Daiichi Sankyo
2025-09-26 PHASE2; PHASE3
NCT07691489 NOT_YET_RECRUITING
Colorectal Cancer; Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum
Memorial Sloan Kettering Cancer Center
2026-08 PHASE2
NCT05555732 ACTIVE_NOT_RECRUITING
Metastatic Non Small Cell Lung Cancer
Daiichi Sankyo
2023-01-11 PHASE3
NCT06780137 RECRUITING
Small Cell Lung Cancer
Merck Sharp & Dohme LLC
2025-02-27 PHASE1; 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
NCT06843447 RECRUITING
Ovarian Cancer Recurrent
Merck Sharp & Dohme LLC
2025-04-15 PHASE1; PHASE2
NCT07291037 RECRUITING
Non-small Cell Lung Cancer (NSCLC)
AstraZeneca
2025-10-31 PHASE3
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
NCT07015697 RECRUITING
Recurrent or Metastatic Solid Tumors
Daiichi Sankyo
2025-07-17 PHASE1
NCT06750484 RECRUITING
Breast Cancer Metastatic
Yale University
2025-06-20 PHASE2
NCT06596694 RECRUITING
Gastrointestinal Cancer
Merck Sharp & Dohme LLC
2024-11-03 PHASE1; PHASE2
NCT06130553 RECRUITING
Advanced Solid Tumors That Are MTAP Deficient
AstraZeneca
2024-01-18 PHASE1; PHASE2
NCT07785856 NOT_YET_RECRUITING
T-dxd Resistant HER2-Positive; HER2 Low Metastatic Breast Cancer
The Methodist Hospital Research Institute
2026-12 PHASE1; PHASE2
NCT07130344 NOT_YET_RECRUITING
Metastatic Breast Cancer; HER 2 Low-expressing Breast Cancer
Centre Paul Strauss
2025-09
NCT06112379 ACTIVE_NOT_RECRUITING
Breast Cancer
AstraZeneca
2023-11-14 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
NCT06819007 RECRUITING
Ovarian Cancer
Daiichi Sankyo
2025-03-19 PHASE3
NCT06630130 RECRUITING
Stomach Neoplasms
Jeeyun Lee
2025-01-22 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
NCT06330064 RECRUITING
Recurrent or Metastatic Solid Tumors
Daiichi Sankyo
2024-04-10 PHASE1; 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
NCT06822543 RECRUITING
Lung Cancer; Non Small Cell Lung Cancer; Brain Metastases
Latin American Cooperative Oncology Group
2025-09-12 PHASE2
NCT06925737 RECRUITING
Prostate Cancer; Prostatic Neoplasms
Merck Sharp & Dohme LLC
2025-05-13 PHASE3
NCT06467357 RECRUITING
Biliary Tract Cancer
AstraZeneca
2024-08-12 PHASE3
NCT06644781 RECRUITING
Esophageal Squamous Cell Carcinoma
Daiichi Sankyo
2025-03-27 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
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
NCT07497386 RECRUITING
Unresectable Locally Recurrent Breast Cancer; Unresectable Locally Metastatic Breast Cancer
Jiangsu HengRui Medicine Co., Ltd.
2026-04-28 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
NCT06350097 RECRUITING
Non-small Cell Lung Cancer
AstraZeneca
2024-04-29 PHASE3
NCT07471776 RECRUITING
Metastatic Breast Cancer ( HER2 Negative)
Fudan University
2026-03-11 PHASE2
NCT06161025 RECRUITING
Solid Cancer
Daiichi Sankyo
2024-02-27 PHASE2; PHASE3
NCT05417594 RECRUITING
Advanced Solid Malignancies
AstraZeneca
2022-06-24 PHASE1; PHASE2
NCT06954480 RECRUITING
Triple Negative Breast Cancer
Queen Mary University of London
2025-10-27 PHASE2
NCT06203210 RECRUITING
Small Cell Lung Cancer
Daiichi Sankyo
2024-05-21 PHASE3
NCT04471727 ACTIVE_NOT_RECRUITING
Small-Cell Lung Cancer; Neuroendocrine Carcinoma
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
2020-12-14 PHASE1; PHASE2
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
NCT07357597 RECRUITING
Stomatitis
AstraZeneca
2026-06-24 PHASE4
NCT03401385 ACTIVE_NOT_RECRUITING
Hormone Receptor Positive Breast Cancer; Triple Negative Breast Cancer; Non-small Cell Lung Cancer
Daiichi Sankyo Co., Ltd.
2018-01-31 PHASE1
NCT06176261 RECRUITING
Breast Cancer; Breast Cancer Female; Metastatic Triple-Negative Breast Carcinoma; ER Positive Breast Cancer; HER2-negative Breast Cancer; HER2 Negative Breast Carcinoma; ER-negative Breast Cancer
Nancy Lin, MD
2024-01-08 PHASE2
NCT06771622 ACTIVE_NOT_RECRUITING
Solid Cancer
FBD Biologics Limited
2025-03-13 PHASE1; PHASE2
NCT06533826 RECRUITING
Breast Cancer; HER2-low Breast Cancer; Metastatic Breast Cancer; HER2-negative Breast Cancer
Ana C Garrido-Castro, MD
2024-10-29 PHASE2
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
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
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
NCT05687266 ACTIVE_NOT_RECRUITING
NSCLC
AstraZeneca
2022-12-29 PHASE3
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
NCT05489211 RECRUITING
Endometrial Cancer; Gastric Cancer; Metastatic Castration-resistant Prostate Cancer; Ovarian Cancer; Colorectal Cancer; Urothelial Cancer; Biliary Tract Cancer
AstraZeneca
2022-09-06 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
NCT06660654 ACTIVE_NOT_RECRUITING
Advanced Solid Tumor; Metastatic Solid Tumors
Daiichi Sankyo
2025-01-06 PHASE2
NCT06058988 RECRUITING
Brain Cancer; Glioblastoma; Metastatic Cancer; Leptomeningeal Metastasis; Recurrent Glioblastoma
Memorial Sloan Kettering Cancer Center
2023-09-22 PHASE2
NCT05629585 ACTIVE_NOT_RECRUITING
Breast Cancer
AstraZeneca
2022-11-28 PHASE3
NCT06172478 RECRUITING
Advanced Solid Tumor; Melanoma; Head and Neck Cancer; Gastric Cancer; Ovarian Carcinoma; Cervical Cancer; Endometrial Cancer; Bladder Cancer; Esophageal Cancer; Pancreatic Carcinoma; Prostate Cancer; Non-small Cell Lung Cancer (NSCLC); Lung Cancer; Breast Cancer
Daiichi Sankyo
2024-02-26 PHASE2
NCT06525298 RECRUITING
Advanced Solid Tumor; Homologous Recombination Deficiency; HRR Deficiency
Eisbach Bio GmbH
2024-09-09 PHASE1; PHASE2
NCT07150208 NOT_YET_RECRUITING
Breast Cancer With Brain Metastasis; HER2-low Expressing Breast Cancer
Fudan University
2025-09 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
NCT07086768 RECRUITING
Solid Tumor; Advanced Solid Tumor; Metastatic Solid Tumor
Lei Zheng
2026-01-26 PHASE1
NCT06676917 WITHDRAWN
Non-small Cell Lung Cancer
MedSIR
2025-06 PHASE2
NCT06103864 RECRUITING
Breast Cancer
AstraZeneca
2023-11-23 PHASE3
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
NCT06564844 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer
AstraZeneca
2024-10-15 PHASE3
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
NCT06974604 RECRUITING
Breast Neoplasms; Lung Neoplasms
Brown University
2025-10-22 PHASE2
NCT04379596 ACTIVE_NOT_RECRUITING
Gastric Cancer
AstraZeneca
2020-06-03 PHASE2
NCT06665178 RECRUITING
Breast Cancer
British Columbia Cancer Agency
2025-03-31 PHASE2
NCT06222489 RECRUITING
Non-Small Cell Lung Carcinoma; Advanced Non-Small Cell Squamous Lung Cancer; EGFR Gene Mutation
The Netherlands Cancer Institute
2025-03-03 PHASE2
NCT06383884 RECRUITING
Solid Tumor, Adult
Samsung Medical Center
2024-08-13 PHASE2
NCT04145622 RECRUITING
Advanced Solid Tumor; Malignant Solid Tumor
Daiichi Sankyo
2019-11-03 PHASE1; 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
NCT04965766 RECRUITING
Metastatic Breast Cancer; Advanced Breast Cancer
Gustave Roussy, Cancer Campus, Grand Paris
2021-05-11 PHASE2
NCT06409390 RECRUITING
Metastatic Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
2024-08-14 PHASE2
NCT06172127 ACTIVE_NOT_RECRUITING
HER2-positive Breast Cancer
MedSIR
2024-07-22 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
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
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
NCT06331169 RECRUITING
Breast Cancer
Fudan University
2024-07-31 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
NCT06250777 ENROLLING_BY_INVITATION
Non Small Cell Lung Cancer
Yonsei University
2024-07-11 PHASE2
NCT04784715 ACTIVE_NOT_RECRUITING
Breast Cancer; HER2-positive; Metastatic
AstraZeneca
2021-04-26 PHASE3
NCT07537673 RECRUITING
Nausea and Vomiting Caused by Trastuzumab Deruxtecan
Second Affiliated Hospital, Zhejiang University, School of Medicine
2025-11-25 PHASE2
NCT06048718 ACTIVE_NOT_RECRUITING
Breast Cancer; Metastatic Breast Cancer
MedSIR
2024-06-05 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
NCT06362252 RECRUITING
Extensive Stage-small Cell Lung Cancer
Daiichi Sankyo
2024-07-22 PHASE1; PHASE2
NCT04704934 ACTIVE_NOT_RECRUITING
Gastric Cancer, Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
Daiichi Sankyo
2021-05-21 PHASE3
NCT06864169 ACTIVE_NOT_RECRUITING
Gastrointestinal Cancer
Merck Sharp & Dohme LLC
2025-04-01 PHASE2
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
NCT05866432 RECRUITING
Breast Cancer Stage IV
Medical University of Vienna
2023-07-01 PHASE2
NCT04612751 ACTIVE_NOT_RECRUITING
Advanced or Metastatic NSCLC
AstraZeneca
2021-02-02 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
NCT05620914 WITHDRAWN
Brain Metastases, Adult
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
2025-07 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
NCT05117476 ACTIVE_NOT_RECRUITING
Advanced Solid Tumor; NSCLC
Cullinan Therapeutics Inc.
2021-10-29 PHASE1
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
NCT05374512 ACTIVE_NOT_RECRUITING
Breast Cancer
AstraZeneca
2022-05-16 PHASE3
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
NCT03944772 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
AstraZeneca
2019-06-25 PHASE2
NCT05480384 ACTIVE_NOT_RECRUITING
Esophageal Adenocarcinoma; Esophageal Cancer; HER-2 Protein Overexpression; Gastroesophageal-junction Cancer
Brown University
2023-07-14 PHASE2
NCT04699630 COMPLETED
Metastatic Breast Cancer; Locally Advanced Breast Cancer
SCRI Development Innovations, LLC
2021-05-03 PHASE2
NCT05569811 ACTIVE_NOT_RECRUITING
Breast Cancer
SOLTI Breast Cancer Research Group
2022-11-25 PHASE2
NCT05113251 ACTIVE_NOT_RECRUITING
Breast Neoplasms; Breast Cancer; HER2-positive Early Breast Cancer
AstraZeneca
2021-10-25 PHASE3
NCT05280470 ACTIVE_NOT_RECRUITING
Extensive-stage Small-cell Lung Cancer
Daiichi Sankyo
2022-03-09 PHASE2
NCT04538742 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
AstraZeneca
2020-12-28 PHASE1; PHASE2
NCT04676477 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer (NSCLC)
Daiichi Sankyo
2021-06-11 PHASE1
NCT03742102 ACTIVE_NOT_RECRUITING
Triple Negative Breast Neoplasms
AstraZeneca
2018-12-21 PHASE1; PHASE2
NCT05865990 COMPLETED
Metastatic Breast Cancer; Advanced Non-Small Cell Squamous Lung Cancer; Solid Tumor, Adult
MedSIR
2023-11-24 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
NCT05338970 ACTIVE_NOT_RECRUITING
Nonsquamous Non-small Cell Lung Cancer; EGFR L858R; EGFR Exon 19 Deletion
Daiichi Sankyo
2022-07-08 PHASE3
NCT06350097 Not yet recruiting
Non-small Cell Lung Cancer
AstraZeneca|Daiichi Sankyo
2024-05-16 Phase 3
NCT06222489 Not yet recruiting
Non-Small Cell Lung Carcinoma|Advanced Non-Small Cell Squamous Lung Cancer|EGFR Gene Mutation
The Netherlands Cancer Institute|Daiichi Sankyo
2024-05-01 Phase 2
NCT04526691 ACTIVE_NOT_RECRUITING
Advanced or Metastatic NSCLC
Daiichi Sankyo
2020-09-15 PHASE1
NCT05620914 Not yet recruiting
Brain Metastases Adult
Mustafa Khasraw MBChB MD FRCP FRACP|Daiichi Sankyo|Duke University
2024-04 Early Phase 1
NCT06331169 Not yet recruiting
Breast Cancer
Fudan University
2024-04-01 Phase 1
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
NCT05458674 Recruiting
Breast Cancer
Criterium Inc.
2024-01-01 Phase 2
NCT05460273 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Cancer
AstraZeneca
2022-07-11 PHASE1; PHASE2
NCT04556773 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
AstraZeneca
2020-12-17 PHASE1
NCT05480384 Recruiting
Esophageal Adenocarcinoma|Esophageal Cancer|HER-2 Protein Overexpression|Gastroesophageal-junction Cancer
Brown University|AstraZeneca
2023-07-14 Phase 2
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
NCT04619004 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer Metastatic; Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
Daiichi Sankyo
2021-02-02 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
NCT04479436 TERMINATED
Metastatic Colorectal Cancer
Daiichi Sankyo
2020-09-14 PHASE2
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
NCT04420598 COMPLETED
Advanced Breast Cancer; HER2-positive Breast Cancer; Brain Metastases; Leptomeningeal Metastasis
MedSIR
2020-05-25 PHASE2
NCT02980341 COMPLETED
Metastatic Breast Cancer
Daiichi Sankyo Co., Ltd.
2016-11-28 PHASE1; 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

(data from https://clinicaltrials.gov, updated on 2026-08-19)

Check the Deruxtecan product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Deruxtecan features a topoisomerase 1 inhibitor derivative payload that stabilizes DNA-topoisomerase I cleavage complexes, thereby inducing single- and double-strand DNA breaks and inhibiting DNA replication. This accumulation of DNA damage triggers apoptotic cell death, driving potent tumor growth inhibition in clinical indications such as breast cancer, non-small cell lung cancer, and gastrointestinal malignancies evaluated in ongoing clinical trials.

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>).

Note: Technical data last updated: Sep 1, 2026.