Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 are evaluating DXd-based antibody-drug conjugates for various oncology indications, including HER2-positive and HER2-low advanced breast cancer, non-small cell lung carcinoma, gastric adenocarcinoma, urothelial carcinoma, and advanced solid malignancies. Led by academic institutions and pharmaceutical sponsors such as Daiichi Sankyo and AstraZeneca, these studies encompass active protocols that are currently recruiting or preparing to enroll patients.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07553390 NOT_YET_RECRUITING
Breast Cancer
M.D. Anderson Cancer Center
 2026-10-01 PHASE1
NCT07776691 NOT_YET_RECRUITING
Ovarian Cancer; Ovarian Neoplasms; Peritoneal Cancer; Fallopian Tube Cancer
Merck Sharp & Dohme LLC
 2026-09-22 PHASE3
NCT06731907 RECRUITING
Non-small Cell Lung Cancer
Merck Sharp & Dohme LLC
 2025-03-30 PHASE2
NCT06780098 RECRUITING
Lung Neoplasm
Merck Sharp & Dohme LLC
 2025-05-28 PHASE2
NCT04165070 RECRUITING
Carcinoma, Non-Small-Cell Lung
Merck Sharp & Dohme LLC
 2019-12-19 PHASE1; PHASE2
NCT06780111 RECRUITING
Esophageal Squamous Cell Carcinoma
Merck Sharp & Dohme LLC
 2025-07-30 PHASE1; PHASE2
NCT07743164 NOT_YET_RECRUITING
Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer
Merck Sharp & Dohme LLC
 2026-10-05 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
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
NCT07220616 RECRUITING
Hematological Malignancies; B-cell Non-Hodgkin Lymphoma
Daiichi Sankyo
 2026-01-16 PHASE1; PHASE2
NCT07227597 RECRUITING
Small Cell Lung Cancer Extensive Stage
Merck Sharp & Dohme LLC
 2026-01-29 PHASE1; PHASE2
NCT07720284 RECRUITING
High-risk Muscle Invasive Urothelial Carcinoma
AstraZeneca
 2026-07-16 PHASE3
NCT07683754 NOT_YET_RECRUITING
Advanced Breast Cancer; Metastatic Breast Cancer; HER2 Positive; HR Positive
Daiichi Sankyo
 2026-09-04 PHASE3
NCT05061550 RECRUITING
Non-small Cell Lung Cancer
AstraZeneca
 2022-04-14 PHASE2
NCT05765851 RECRUITING
Advanced Solid Tumor
Daiichi Sankyo
 2023-05-30 PHASE1
NCT07459673 RECRUITING
Breast Cancer; HER2-positive Breast Cancer; Breast Cancer Stage IV
Memorial Sloan Kettering Cancer Center
 2026-03-04 PHASE2
NCT05215340 ACTIVE_NOT_RECRUITING
Metastatic Non Small Cell Lung Cancer
Daiichi Sankyo
 2022-03-04 PHASE3
NCT06357533 RECRUITING
Non-Small Cell Lung Cancer
AstraZeneca
 2024-04-11 PHASE3
NCT04938817 ACTIVE_NOT_RECRUITING
Small Cell Lung Carcinoma
Merck Sharp & Dohme LLC
 2021-08-19 PHASE1; PHASE2
NCT07371585 RECRUITING
Breast Cancer Stage IV
SOLTI Breast Cancer Research Group
 2026-02-18 PHASE2
NCT07738341 NOT_YET_RECRUITING
Breast Cancer (Locally Advanced or Metastatic)
Eddingpharm (Zhuhai) Co., Ltd.
 2026-08-01 PHASE1; 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
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
NCT07098338 RECRUITING
Non-Small Cell Lung Cancer
AstraZeneca
 2025-08-07 PHASE2
NCT07417241 NOT_YET_RECRUITING
Breast Cancer; HER2-positive Breast Cancer
Peking University Cancer Hospital & Institute
 2026-03-31 PHASE2
NCT07291037 RECRUITING
Non-small Cell Lung Cancer (NSCLC)
AstraZeneca
 2025-10-31 PHASE3
NCT06989112 RECRUITING
Endometrial Cancer
AstraZeneca
 2025-03-27 PHASE3
NCT07785856 NOT_YET_RECRUITING
T-dxd Resistant HER2-Positive; HER2 Low Metastatic Breast Cancer
The Methodist Hospital Research Institute
 2026-12 PHASE1; PHASE2
NCT06112379 ACTIVE_NOT_RECRUITING
Breast Cancer
AstraZeneca
 2023-11-14 PHASE3
NCT06244485 ACTIVE_NOT_RECRUITING
Advanced Solid Tumor
Daiichi Sankyo
 2024-02-16 PHASE1
NCT07182721 RECRUITING
HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer; SKB264; Inetetamab
Fudan University
 2025-09-30 PHASE2
NCT06330064 RECRUITING
Recurrent or Metastatic Solid Tumors
Daiichi Sankyo
 2024-04-10 PHASE1; PHASE2
NCT06467357 RECRUITING
Biliary Tract Cancer
AstraZeneca
 2024-08-12 PHASE3
NCT06644781 RECRUITING
Esophageal Squamous Cell Carcinoma
Daiichi Sankyo
 2025-03-27 PHASE3
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
NCT06445972 RECRUITING
Gastroesophageal Junction; Gastroesophageal Adenocarcinoma; Esophageal Neoplasms; Esophageal Cancer
Merck Sharp & Dohme LLC
 2024-08-07 PHASE1; PHASE2
NCT07535437 RECRUITING
Non-Small Cell Lung Cancer
Memorial Sloan Kettering Cancer Center
 2026-04-09 PHASE1; PHASE2
NCT05034887 ACTIVE_NOT_RECRUITING
Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
National Cancer Center Hospital East
 2022-01-31 PHASE2
NCT06350097 RECRUITING
Non-small Cell Lung Cancer
AstraZeneca
 2024-04-29 PHASE3
NCT07465172 NOT_YET_RECRUITING
Breast Cancer
Breast Cancer Trials, Australia and New Zealand
 2026-03
NCT06161025 RECRUITING
Solid Cancer
Daiichi Sankyo
 2024-02-27 PHASE2; PHASE3
NCT05417594 RECRUITING
Advanced Solid Malignancies
AstraZeneca
 2022-06-24 PHASE1; PHASE2
NCT07205822 RECRUITING
Breast Cancer
AstraZeneca
 2025-10-30 PHASE3
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
NCT07294508 RECRUITING
HER2 + Breast Cancer
Shanghai Henlius Biotech
 2026-02-27 PHASE2; PHASE3
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
NCT06733233 NOT_YET_RECRUITING
Breast Cancer, Estrogen Receptor-Positive; HER2 Low Breast Cancer
Guangzhou Women and Children's Medical Center
 2025-01-01 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
NCT07162259 NOT_YET_RECRUITING
Breast Neoplasms
Yan Xue
 2025-10-01 PHASE4
NCT07662473 NOT_YET_RECRUITING
NSCLC
Hunan Province Tumor Hospital
 2026-07-29 PHASE2
NCT07069712 RECRUITING
Gastroesophageal Adenocarcinoma
AstraZeneca
 2025-07-17 PHASE2
NCT05687266 ACTIVE_NOT_RECRUITING
NSCLC
AstraZeneca
 2022-12-29 PHASE3
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
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
NCT05950945 RECRUITING
Breast Cancer
Daiichi Sankyo
 2023-12-30 PHASE3
NCT06610825 RECRUITING
Prostate Cancer Metastatic; Prostate Cancer; CRPC
Washington D.C. Veterans Affairs Medical Center
 2025-03-05 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
NCT05593094 ACTIVE_NOT_RECRUITING
Advanced Solid Tumors; HER2-positive Breast Cancer
Hoffmann-La Roche
 2020-09-03 PHASE1; PHASE2
NCT06103864 RECRUITING
Breast Cancer
AstraZeneca
 2023-11-23 PHASE3
NCT04686305 RECRUITING
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
AstraZeneca
 2021-03-09 PHASE1
NCT06564844 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer
AstraZeneca
 2024-10-15 PHASE3
NCT07405151 RECRUITING
Oesophageal Squamous Cell Carcinoma
Merck Sharp & Dohme LLC
 2026-03-27 PHASE1; PHASE2
NCT06832202 RECRUITING
HER2-low Hormone Receptor Positive Breast Cancer
Shanghai Henlius Biotech
 2025-04-16 PHASE2
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
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
NCT04145622 RECRUITING
Advanced Solid Tumor; Malignant Solid Tumor
Daiichi Sankyo
 2019-11-03 PHASE1; PHASE2
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
NCT07416253 NOT_YET_RECRUITING
Breast Cancer
Henan Cancer Hospital
 2026-03 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
NCT07254416 NOT_YET_RECRUITING
Breast Cancer Patients Treated With T-DXd
Tianjin Medical University Cancer Institute and Hospital
 2025-12-15 PHASE4
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
NCT06578286 NOT_YET_RECRUITING
Breast Cancer
Fudan University
 2024-09-30 PHASE2
NCT06417814 RECRUITING
Metastatic Non-small Cell Lung Cancer
AstraZeneca
 2024-10-04 PHASE3
NCT06362252 RECRUITING
Extensive Stage-small Cell Lung Cancer
Daiichi Sankyo
 2024-07-22 PHASE1; PHASE2
NCT07134153 RECRUITING
Breast Cancer
Fudan University
 2025-04-18 PHASE1; PHASE2
NCT06864169 ACTIVE_NOT_RECRUITING
Gastrointestinal Cancer
Merck Sharp & Dohme LLC
 2025-04-01 PHASE2
NCT06174987 RECRUITING
Advanced Cancer; Metastatic Cancer
Daiichi Sankyo
 2024-01-05 PHASE3
NCT07117864 RECRUITING
Breast Cancer
QIAO LI
 2025-07-01
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
NCT03260491 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer (NSCLC)
Daiichi Sankyo
 2017-10-30 PHASE1
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
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
NCT06508216 RECRUITING
Breast Cancer
Gustave Roussy, Cancer Campus, Grand Paris
 2024-07-05 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
NCT06548178 NOT_YET_RECRUITING
HER2-positive Breast Cancer
Fudan University
 2024-09 PHASE2
NCT05374512 ACTIVE_NOT_RECRUITING
Breast Cancer
AstraZeneca
 2022-05-16 PHASE3
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
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
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
NCT05104866 ACTIVE_NOT_RECRUITING
Breast Cancer
AstraZeneca
 2021-10-18 PHASE3
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
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
NCT06330064 Recruiting
Recurrent or Metastatic Solid Tumors
Daiichi Sankyo|Merck Sharp & Dohme LLC
 2024-04-10 Phase 2
NCT05620914 Not yet recruiting
Brain Metastases Adult
Mustafa Khasraw MBChB MD FRCP FRACP|Daiichi Sankyo|Duke University
 2024-04 Early Phase 1
NCT04494425 ACTIVE_NOT_RECRUITING
Advanced or Metastatic Breast Cancer
AstraZeneca
 2020-07-24 PHASE3
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
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
NCT03529110 ACTIVE_NOT_RECRUITING
Breast Cancer
Daiichi Sankyo
 2018-08-09 PHASE3

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

Check the Dxd (Exatecan derivative for ADC) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dxd potently inhibits DNA topoisomerase I with an IC50 of 0.31 μM, stabilizing topoisomerase I-DNA cleavage complexes and generating double-strand DNA breaks during replication to induce cell cycle arrest and apoptotic cell death. This topoisomerase-mediated cytotoxic activity provides the biological foundation for its application as an antibody-drug conjugate payload in clinical trials targeting HER2-expressing breast cancer, non-small cell lung carcinoma, and other solid malignancies.

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>).

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