Datopotamab Deruxtecan — Drug Intelligence | 27 EU Trials

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27 Registered trials

11 Recruiting

13 Completed trials

5 Sponsors

18 Countries

Phase III

Phase II

Phase III: 14 Phase II/III: 1 Phase II: 7 Phase I/II: 1 Phase I (Other): 2 Phase I (FiH): 2

Oversight events:

2 serious breaches 17 temporary halts 1 urgent safety measure across 4 trials

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Indications tested

Non-small cell lung cancer 8 Triple negative breast cancer 4 Non-small cell lung cancer stage III 1 Prostate cancer 1 Bladder cancer 1 Metastatic glioma 1 Non-small cell lung cancer stage II 1 Ovarian cancer 1 Metastases to biliary tract 1 Non-small cell lung cancer stage IIIB 1 Hormone refractory breast cancer 1 Non-small cell lung cancer stage I 1

Sponsors using this IMP

AstraZeneca AB 18 Daiichi Sankyo Inc. 6 Medica Scientia Innovation Research S.L. 1 Medical University Of Vienna 1 Queen Mary University Of London 1

All trials

27 total

A phase 2 study to research the safety and efficacy of datopotamab deruxtecan for non-squamous non-small cell lung cancer patients with acti… Not authorised

2024-512369-14-00 Phase II 2 countries Medica Scientia Innovation Research S.L.
A trial to learn how well Dato-DXd and rilvegostomig work and how safe they are in participants with stage I adenocarcinoma non-small cell l… Pending

2024-512195-35-00 Phase III 9 countries AstraZeneca AB
Dato-DXd plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Previously Treated la/mUC. Recruiting

2024-516906-47-00 Phase II/III 11 countries Daiichi Sankyo Inc.
Phase II Study of daTopotamab-derUXtecan (Dato-DXd; DS-1026a) in triple-negative brEast cancer patients with newly Diagnosed or prOgressing … Recruiting

2024-518819-19-00 Phase II 2 countries Medical University Of Vienna
A trial to learn how effective and safe datopotamab deruxtecan (Dato-DXd) is compared to docetaxel and how well Dato-DXd works in adults wit… Recruiting

2024-520101-39-00 Phase III 8 countries AstraZeneca AB
A trial to learn how safe Dato-DXd is and how well it works in people with NSCLC that has advanced after receiving osimertinib Recruiting

2024-511362-37-00 Phase III 7 countries AstraZeneca AB
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer Recruiting

2025-521904-23-00 Phase II 3 countries AstraZeneca AB
An open-label randomised, phase II trial of Datopotamab deruxtecan plus Durvalumab versus Datopotamab deruxtecan in patients with PDL1-negat… Recruiting

2024-519913-76-00 Phase II 2 countries Queen Mary University Of London
A trial to learn if Dato-DXd with rilvegostomig, or rilvegostomig alone, is safe and works compared with pembrolizumab in people who have ad… Recruiting

2023-505077-32-00 Phase III 7 countries AstraZeneca AB
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizum… Recruiting

2023-503675-24-00 Phase III 4 countries AstraZeneca AB
A trial to learn how safe Dato-DXd is when given with osimertinib, and how well it works compared to osimertinib alone in people who have ad… Recruiting

2023-509883-89-00 Phase III 5 countries AstraZeneca AB
Study of AZD9574 as monotherapy and in combination with anti-cancer agents in patients with advanced solid malignancies Recruiting

2023-504984-17-00 Phase I (FiH) 2 countries AstraZeneca AB
Study of Neoadjuvant and Adjuvant Treatment in Patients with Resectable Non-small Cell Lung Cancer Recruiting

2023-508852-21-00 Phase II 7 countries AstraZeneca AB
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab Injections Before and After Surgery for the Treatment of Adult Patients wit… Ended

2023-505928-59-00 Phase III 9 countries Astrazeneca AB
A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with N… Ended

2022-500802-16-00 Phase III 13 countries Daiichi Sankyo Inc.
A Study of Dato-DXd With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast C… Ended

2023-505552-22-00 Phase III 8 countries Astrazeneca AB
A Study of Dato-DXd in Combination With Durvalumab and Carboplatin for First-line Treatment of Advanced NSCLC Without Actionable Genomic Alt… Ended

2023-505993-14-00 Phase III 10 countries Astrazeneca AB
Phase 1b Study of Dato-DXd in Combination with Immunotherapy with or without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cance… Ended

2023-505992-54-00 Phase I (Other) 4 countries Astrazeneca AB
Study of DS-1062a with or without Pembrolizumab in Advanced or Metastatic Non-small Cell Lung Cancer without Actionable Genomic Alterations Ended

2023-507933-12-00 Phase III 12 countries Daiichi Sankyo Inc.
A trial to learn how well Dato-DXd works and how safe it is compared to standard chemotherapy in adults with triple-negative breast cancer (… Ended

2023-509260-25-00 Phase III 7 countries AstraZeneca AB
A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Inoperable or Metastatic Hormone Receptor-positive, HER2-negative Breast Ca… Ended

2023-509631-37-00 Phase III 7 countries AstraZeneca AB
Study of AZD5305 as Monotherapy and with Anti-Cancer Agents in Patients with Advanced Solid Malignancies Ended

2022-502856-29-00 Phase I (FiH) 5 countries AstraZeneca AB
DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer Ended

2023-509865-19-00 Phase III 7 countries Daiichi Sankyo Inc.
A trial to learn if different cancer treatment combinations are safe and work in people with advanced non-small cell lung cancer that has mu… Ended

2023-504624-25-00 Phase II 5 countries AstraZeneca AB

Showing 1–24 of 27 trials

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