Compound · clinical trials

Dato-DXd clinical trials

Also listed in trial records as DS-1062a, Datopotamab Deruxtecan, Datroway, DS1062a, DS-1062, S-1062a

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 40 trials in our USA, Spain, Japan, Italy, South Korea, China, Taiwan, France, Canada, Poland, UK, Germany, Brazil, Australia, Turkey, Belgium, India, Austria, Singapore, Netherlands, Mexico, Switzerland, Israel, Sweden, Portugal, Czechia, Denmark, Ireland, Egypt and Norway registers that name Dato-DXd as an intervention. Synced 9 Nov 2026

40Current trials

18Recruiting now

10Lead sponsors

30Country registers

Maintained by Sreepriya Prasannan

MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist

Compiled from ClinicalTrials.gov registry records · Synced 9 Nov 2026 · Editorial standards

At a glance

Dato-DXd is named as an intervention in 40 current clinical trials in our USA, Spain, Japan, Italy, South Korea, China, Taiwan, France, Canada, Poland, UK, Germany, Brazil, Australia, Turkey, Belgium, India, Austria, Singapore, Netherlands, Mexico, Switzerland, Israel, Sweden, Portugal, Czechia, Denmark, Ireland, Egypt and Norway registers. 18 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is AstraZeneca (24). The most-studied condition is Breast Cancer. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.

Where Dato-DXd is approved

All regulators →

Of the three regulators tracked here, the first to approve Dato-DXd was the US, on 17 Jan 2025. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)

17 Jan 2025

Datroway

BLA761394 on Drugs@FDA

First original NDA/BLA approval

EUEuropean Union (EMA)

4 Apr 2025

Datroway

EMA product page

First centralised authorisation

CACanada (Health Canada)

No new-drug Notice of Compliance since 1994

First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Dato-DXd

All medicines →

ENNHS England

Not dispensed in the community in England in the last 12 months under this name

Net ingredient cost, community prescriptions

USUS Medicaid

$1.7m

129 prescriptions in 2025 · Datroway

Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Dato-DXd works

All drug targets →

Tumor-associated calcium signal transducer 2 binding agent Binding agent
Target: TACSTD2 tumor associated calcium signal transducer 2
✓ In ChEMBL and the Guide to Pharmacology
DNA topoisomerase I inhibitor Inhibitor
Target: TOP1 DNA topoisomerase I
ChEMBL only

Other medicines acting on TACSTD2

Sacituzumab Govitecan

Other medicines acting on TOP1

Irinotecan Trastuzumab deruxtecan Sacituzumab Govitecan Topotecan Patritumab deruxtecan Irinotecan Sucrosofate

Diseases it has been tested for in clinical trials, by furthest phase

Triple-negative breast carcinomaPhase 3
Urothelial carcinomaPhase 2/3
Biliary tract cancerPhase 2
CancerPhase 2
Colorectal cancerPhase 2
Colorectal carcinomaPhase 2
Endometrial cancerPhase 2
Endometrial carcinomaPhase 2
Gastric cancerPhase 2
Gastric neoplasmPhase 2

23 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297939, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 13304, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Dato-DXd

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

EU
European Union: Datroway
EMA product information: package leaflet and summary of product characteristics in every EU language.
UK
United Kingdom: Search MHRA Products
Patient information leaflets and SmPCs for UK-licensed products.
US
United States: Search DailyMed
FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

Recruiting1845%
Not yet open13%
Active, closed2153%

Trials by phase

Phase 31640%
Phase 2923%
Phase 1/2718%
Phase 1513%
Phase 413%
Phase 2/313%
Observational13%

Clinical trials of Dato-DXd

40 trials

Study	Phase	Status	Lead sponsor	Registers
An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer. NCT07357597 · Stomatitis	Phase 4	Recruiting	AstraZeneca	USA
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05) NCT06103864 · Breast Cancer	Phase 3	Recruiting	AstraZeneca	UK, USA, India, China, Germany, France, Spain, Italy, Poland, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Singapore, Australia
Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer NCT06350097 · Non-small Cell Lung Cancer	Phase 3	Recruiting	AstraZeneca	USA, India, China, Germany, France, Spain, Italy, Poland, Turkey, Canada, Brazil, Japan, South Korea, Taiwan, Australia
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations NCT06357533 · Non-Small Cell Lung Cancer	Phase 3	Recruiting	AstraZeneca	UK, USA, India, China, Germany, Spain, Italy, Belgium, Poland, Austria, Turkey, Canada, Brazil, Japan, South Korea, Taiwan, Australia
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer NCT07205822 · Breast Cancer	Phase 3	Recruiting	AstraZeneca	USA, China, France, Spain, Italy, South Korea
Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations NCT07291037 · Non-small Cell Lung Cancer (NSCLC)	Phase 3	Recruiting	AstraZeneca	UK, USA, India, China, Germany, France, Spain, Italy, Belgium, Poland, Austria, Turkey, Canada, Brazil, Japan, South Korea, Taiwan, Australia, Egypt
An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC NCT07720284 · High-risk Muscle Invasive Urothelial Carcinoma	Phase 3	Recruiting	AstraZeneca	UK, USA, India, China, Germany, France, Spain, Italy, Poland, Canada, Brazil, Japan, South Korea, Taiwan, Australia
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma NCT07129993 · Urothelial Cancer, Bladder Cancer	Phase 2/3	Recruiting	Daiichi Sankyo	USA, China, Germany, France, Italy, Austria, Japan
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer NCT05061550 · Non-small Cell Lung Cancer	Phase 2	Recruiting	AstraZeneca	Ireland, USA, France, Spain, Italy, Belgium, Portugal, Turkey, Canada, South Korea, Taiwan
Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) NCT05489211 · Endometrial Cancer, Gastric Cancer, Metastatic Castration-resistant Prostate Cancer	Phase 2	Recruiting	AstraZeneca	UK, USA, China, Germany, France, Spain, Italy, Poland, Switzerland, Turkey, Canada, Japan, South Korea, Taiwan
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd NCT06533826 · Breast Cancer, HER2-low Breast Cancer, Metastatic Breast Cancer	Phase 2	Recruiting	Ana C Garrido-Castro, MD	Israel
A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer) NCT06822543 · ClinicalTrials.gov ↗ · Lung Cancer, Non Small Cell Lung Cancer, Brain Metastases	Phase 2	Recruiting	Latin American Cooperative Oncology Group	Brazil
A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC) NCT07098338 · Non-Small Cell Lung Cancer	Phase 2	Recruiting	AstraZeneca	USA, China, France, Spain, Italy, Canada, Japan, South Korea, Taiwan, Singapore, Australia
Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies NCT05417594 · Advanced Solid Malignancies	Phase 1/2	Recruiting	AstraZeneca	UK, USA, Germany, Spain, Sweden, South Korea, Australia
A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors NCT06130553 · Advanced Solid Tumors That Are MTAP Deficient	Phase 1/2	Recruiting	AstraZeneca	USA, China, France, Spain, Netherlands, Japan, South Korea, Australia
A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer NCT06508216 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 1/2	Recruiting	Gustave Roussy, Cancer Campus, Grand Paris	France
A Study of Dato-DXd in Participants With Solid Tumors [TROPION-PanTumor04 (TP04)] NCT07890714 · ClinicalTrials.gov ↗ · Urothelial Cancer, Non-small Cell Lung Cancer	Phase 1/2	Recruiting	Daiichi Sankyo	Taiwan
Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response NCT07582887 · ClinicalTrials.gov ↗ · Breast Cancer, Metastatic Breast Cancer, Drug-Related Side Effects and Adverse Reactions	Observational	Recruiting	Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental	Spain
Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer NCT07825753 · ClinicalTrials.gov ↗ · Advanced or Metastatic Pancreatic Adenocarcinoma, Advanced or Metastatic Breast Cancer (BC)	Phase 2	Not yet open	Fudan University	China
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) NCT04656652 · Non-small Cell Lung Cancer	Phase 3	Active, closed	Daiichi Sankyo	UK, USA, China, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Switzerland, Czechia, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Singapore, Australia
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) NCT05104866 · Breast Cancer	Phase 3	Active, closed	AstraZeneca	UK, USA, India, China, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Canada, Brazil, Japan, South Korea, Taiwan
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations NCT05215340 · Metastatic Non Small Cell Lung Cancer	Phase 3	Active, closed	Daiichi Sankyo	UK, USA, China, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Switzerland, Austria, Portugal, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Australia, Israel
A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02) NCT05374512 · Breast Cancer	Phase 3	Active, closed	AstraZeneca	UK, USA, India, China, Germany, France, Spain, Italy, Belgium, Poland, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Singapore
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) NCT05555732 · Metastatic Non Small Cell Lung Cancer	Phase 3	Active, closed	Daiichi Sankyo	UK, USA, China, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Switzerland, Austria, Czechia, Portugal, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Australia, Israel
A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03) NCT05629585 · Breast Cancer	Phase 3	Active, closed	AstraZeneca	UK, USA, China, Germany, France, Spain, Italy, Belgium, Sweden, Denmark, Canada, Brazil, Japan, South Korea, Taiwan
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations NCT05687266 · NSCLC	Phase 3	Active, closed	AstraZeneca	UK, USA, India, China, Germany, France, Spain, Italy, Sweden, Poland, Austria, Turkey, Canada, Brazil, Mexico, Japan, South Korea, Taiwan
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer NCT06112379 · Breast Cancer	Phase 3	Active, closed	AstraZeneca	UK, USA, India, China, Germany, France, Spain, Italy, Belgium, Poland, Switzerland, Austria, Turkey, Canada, Brazil, Japan, South Korea, Taiwan, Singapore, Australia
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer NCT06417814 · Metastatic Non-small Cell Lung Cancer	Phase 3	Active, closed	AstraZeneca	UK, USA, India, China, Germany, France, Spain, Italy, Belgium, Poland, Canada, Brazil, Japan, South Korea, Taiwan, Singapore, Australia, Israel
A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features NCT06564844 · Non-small Cell Lung Cancer	Phase 3	Active, closed	AstraZeneca	USA, Turkey, Canada, Brazil, Japan, Taiwan
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) NCT03944772 · Non-Small Cell Lung Cancer	Phase 2	Active, closed	AstraZeneca	USA, Spain, Italy, Netherlands, Sweden, Denmark, Norway, Japan, South Korea
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer NCT04940325 · ClinicalTrials.gov ↗ · Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer, Unresectable Non-small Lung Cancer	Phase 2	Active, closed	Gustave Roussy, Cancer Campus, Grand Paris	France
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases NCT05866432 · ClinicalTrials.gov ↗ · Breast Cancer Stage IV	Phase 2	Active, closed	Medical University of Vienna	Austria
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer NCT03742102 · Triple Negative Breast Neoplasms	Phase 1/2	Active, closed	AstraZeneca	UK, USA, Poland, Canada, South Korea, Taiwan
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies NCT04644068 · Ovarian Cancer, Breast Cancer, Pancreatic Cancer	Phase 1/2	Active, closed	AstraZeneca	UK, USA, China, Spain, Italy, Poland, Czechia, Canada, Japan, South Korea, Australia
A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02) NCT05460273 · ClinicalTrials.gov ↗ · Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Cancer	Phase 1/2	Active, closed	AstraZeneca	China
First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01) NCT03401385 · Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer, Non-small Cell Lung Cancer	Phase 1	Active, closed	Daiichi Sankyo Co., Ltd	USA, Japan
Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02) NCT04526691 · Advanced or Metastatic NSCLC	Phase 1	Active, closed	Daiichi Sankyo	USA, Spain, Italy, Japan, Taiwan
Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer NCT04612751 · Advanced or Metastatic NSCLC	Phase 1	Active, closed	AstraZeneca	USA, Spain, Italy, Belgium, Poland, Turkey, Japan, Taiwan
A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors NCT05117476 · Advanced Solid Tumor, NSCLC	Phase 1	Active, closed	Cullinan Therapeutics Inc	USA, Spain, Poland, Australia
A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors NCT06244485 · Advanced Solid Tumor	Phase 1	Active, closed	Daiichi Sankyo	USA, China, Italy, Japan

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

Dato-DXd in the EU trials register (CTIS)

2 trials

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Dato-DXd. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

Study	Phase	Status	Sponsor	Countries
A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma (TROPION-Urothelial04). 2025-525030-57-00 · Neoplasms	Phase 3	Ongoing	AstraZeneca AB	Italy, Poland, Spain + 2 more
A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Participants with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who Progressed During or After Enfortumab Vedotin (EV) plus Pembrolizumab Combination Treatment. TROPION-Urothelial03 (TU03). 2024-516906-47-00 · CTIS ↗ · Neoplasms	Phase 3	Ongoing	Daiichi Sankyo Inc	Netherlands, Germany, Norway + 8 more

Conditions studied with Dato-DXd

39 conditions

Breast Cancer10 Non-small Cell Lung Cancer6 Non-Small Cell Lung Cancer3 Metastatic Non Small Cell Lung Cancer2 Ovarian Cancer2 NSCLC2Advanced or Metastatic NSCLC2Advanced Solid Tumor2 Urothelial Cancer2 Triple Negative Breast Cancer2 Metastatic Breast Cancer2High-risk Muscle Invasive Urothelial Carcinoma1

All 39 conditions

Condition (as registered)	Trials
Breast Cancer	10
Non-small Cell Lung Cancer	6
Non-Small Cell Lung Cancer	3
Metastatic Non Small Cell Lung Cancer	2
Ovarian Cancer	2
NSCLC	2
Advanced or Metastatic NSCLC	2
Advanced Solid Tumor	2
Urothelial Cancer	2
Triple Negative Breast Cancer	2
Metastatic Breast Cancer	2
High-risk Muscle Invasive Urothelial Carcinoma	1
Triple Negative Breast Neoplasms	1
Advanced Solid Malignancies	1
Non-small Cell Lung Cancer (NSCLC)	1
Endometrial Cancer	1
Gastric Cancer	1
Metastatic Castration-resistant Prostate Cancer	1
Metastatic Non-small Cell Lung Cancer	1
Pancreatic Cancer	1
Prostate Cancer	1
Stomatitis	1
Bladder Cancer	1
Advanced Solid Tumors That Are MTAP Deficient	1
Hormone Receptor Positive Breast Cancer	1
Carcinoma, Non-Small-Cell Lung	1
Advanced or Metastatic Pancreatic Adenocarcinoma	1
Advanced or Metastatic Breast Cancer (BC)	1
HER2-low Breast Cancer	1
HER2-negative Breast Cancer	1
Metastatic Lung Cancer	1
Advanced Non Small Cell Lung Cancer	1
Unresectable Non-small Lung Cancer	1
Drug-Related Side Effects and Adverse Reactions	1
Pharmacogenetic Variant	1
Breast Cancer Stage IV	1
Lung Cancer	1
Non Small Cell Lung Cancer	1
Brain Metastases	1

By country register

Register	Trials	Recruiting
Clinical trials in USA	31	13
Clinical trials in Spain	26	12
Clinical trials in Japan	25	9
Clinical trials in Italy	24	10
Clinical trials in South Korea	23	11
Clinical trials in China	23	10
Clinical trials in Taiwan	22	9
Clinical trials in France	21	11
Clinical trials in Canada	20	8
Clinical trials in Poland	18	6
Clinical trials in UK	17	6
Clinical trials in Germany	17	8
Clinical trials in Brazil	16	6
Clinical trials in Australia	15	8
Clinical trials in Turkey	13	6
Clinical trials in Belgium	12	3
Clinical trials in India	10	5
Clinical trials in Austria	8	3
Clinical trials in Singapore	6	2
Clinical trials in Netherlands	6	1
Clinical trials in Mexico	6	1
Clinical trials in Switzerland	5	1
Clinical trials in Israel	4	1
Clinical trials in Sweden	4	1
Clinical trials in Portugal	3	1
Clinical trials in Czechia	3	0
Clinical trials in Denmark	2	0
Clinical trials in Ireland	1	1
Clinical trials in Egypt	1	1
Clinical trials in Norway	1	0
EU register (CTIS)	2	—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

Related compounds

Questions about Dato-DXd trials

How many clinical trials are testing Dato-DXd?

40 current trials in our USA, Spain, Japan, Italy, South Korea, China, Taiwan, France, Canada, Poland, UK, Germany, Brazil, Australia, Turkey, Belgium, India, Austria, Singapore, Netherlands, Mexico, Switzerland, Israel, Sweden, Portugal, Czechia, Denmark, Ireland, Egypt and Norway registers name Dato-DXd (also registered as DS-1062a) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Dato-DXd trials recruiting patients?

Yes. 18 of the 40 trials are recruiting: 13 with sites in USA, 12 with sites in Spain, 9 with sites in Japan, 10 with sites in Italy, 11 with sites in South Korea, 10 with sites in China, 9 with sites in Taiwan, 11 with sites in France, 8 with sites in Canada, 6 with sites in Poland, 6 with sites in UK, 8 with sites in Germany, 6 with sites in Brazil, 8 with sites in Australia, 6 with sites in Turkey, 3 with sites in Belgium, 5 with sites in India, 3 with sites in Austria, 2 with sites in Singapore, 1 with sites in Netherlands, 1 with sites in Mexico, 1 with sites in Switzerland, 1 with sites in Israel, 1 with sites in Sweden, 1 with sites in Portugal, 1 with sites in Ireland and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Dato-DXd clinical trials?

AstraZeneca (24), Daiichi Sankyo (7), Gustave Roussy, Cancer Campus, Grand Paris (2) and Cullinan Therapeutics Inc (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Are there Dato-DXd clinical trials in Ireland?

Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Dato-DXd works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Dato-DXd works or whether it is effective. Each trial links to its own record so you can check it yourself.

ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Dato-DXd (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.