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Dato-DXd

DRUG13 trials

Sponsors

AstraZeneca, Daiichi Sankyo, Gustave Roussy, Cancer Campus, Grand Paris

Conditions

Additional Indications Below for Module 4 and 5Advanced Solid TumorBiliary CancerBladder CancerBreast CancerCervical CancerColorectal CancerEndometrial Cancer

Phase 1

Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
Active, not recruitingNCT04644068
AstraZenecaAdditional Indications Below for Module 4 and 5, Biliary Cancer, Bladder Cancer +10
Start: 2020-11-12End: 2027-05-28Updated: 2026-02-19
A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
RecruitingNCT06244485
Daiichi SankyoAdvanced Solid Tumor
Start: 2024-02-16End: 2028-11-01Target: 210Updated: 2026-02-04
A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
RecruitingNCT06508216
Gustave Roussy, Cancer Campus, Grand ParisBreast Cancer
Start: 2024-07-05End: 2027-12-17Target: 50Updated: 2024-07-22

Phase 2

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
RecruitingNCT05061550
AstraZenecaNon-small Cell Lung Cancer
Start: 2022-04-14End: 2030-05-28Target: 630Updated: 2026-03-11
A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
RecruitingNCT07098338
AstraZenecaNon-Small Cell Lung Cancer
Start: 2025-08-07End: 2029-04-06Target: 278Updated: 2026-02-05
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
RecruitingNCT07129993
Daiichi SankyoBladder Cancer, Urothelial Cancer
Start: 2025-09-26End: 2030-01-22Target: 630Updated: 2026-03-19

Phase 3

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)
Active, not recruitingNCT05104866
AstraZenecaBreast Cancer
Start: 2021-10-18End: 2026-07-31Updated: 2026-02-04
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)
Active, not recruitingNCT05374512
AstraZenecaBreast Cancer
Start: 2022-05-16End: 2028-11-03Updated: 2026-01-27
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)
Active, not recruitingNCT05629585
AstraZenecaBreast Cancer
Start: 2022-11-28End: 2030-01-30Updated: 2026-03-18
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
RecruitingNCT06103864
AstraZenecaBreast Cancer
Start: 2023-11-23End: 2030-09-30Target: 625Updated: 2026-03-31
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
Active, not recruitingNCT06112379
AstraZenecaBreast Cancer
Start: 2023-11-14End: 2032-09-23Updated: 2026-04-02
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
RecruitingNCT06417814
AstraZenecaMetastatic Non-small Cell Lung Cancer
Start: 2024-10-04End: 2028-09-27Target: 744Updated: 2026-03-02
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
RecruitingNCT07205822
AstraZenecaBreast Cancer
Start: 2025-10-30End: 2028-02-02Target: 100Updated: 2026-03-18

Related Papers

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Clinical Cancer Research2026-02-17
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2025-12-23
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261TiP TROPION-Breast05: Phase (Ph) III study of datopotamab deruxtecan (Dato-DXd) ± durvalumab (D) vs chemotherapy (CT) + pembrolizumab (pembro) in patients (pts) with PD-L1+ locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC)
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18 more papers not shown