Datopotamab Deruxtecan (Dato-DXd)

DRUG9 trials

Sponsors

Daiichi Sankyo Co., Ltd., AstraZeneca, Queen Mary University of London, Eddingpharm (Zhuhai) Co., Ltd., Fudan University

Conditions

Advanced Solid MalignanciesAdvanced or Metastatic Breast Cancer (BC)Advanced or Metastatic Pancreatic AdenocarcinomaBiliary Tract CancerBreast Cancer (Locally Advanced or Metastatic)Carcinoma, Non-Small-Cell LungColorectal CancerEndometrial Cancer

Phase 1

First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

Active, not recruitingNCT03401385

Daiichi Sankyo Co., Ltd.Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer

Start: 2018-01-31End: 2028-01-01Target: 890Updated: 2026-09-01

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

RecruitingNCT05417594

AstraZenecaAdvanced Solid Malignancies

Start: 2022-06-24End: 2028-02-07Target: 695Updated: 2026-10-05

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)

Active, not recruitingNCT05460273

AstraZenecaCarcinoma, Non-Small-Cell Lung, Triple Negative Breast Cancer

Start: 2022-07-11End: 2027-06-30Updated: 2026-08-31

GB268 Monotherapy or Combination Therapy for Locally Advanced/Metastatic Breast Cancer (Phase Ib/Ⅱ)

Not yet recruitingNCT07738341

Eddingpharm (Zhuhai) Co., Ltd.Breast Cancer (Locally Advanced or Metastatic)

Start: 2026-08-01End: 2030-08-01Target: 270Updated: 2026-07-31

Phase 2

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

RecruitingNCT05489211

AstraZenecaBiliary Tract Cancer, Colorectal Cancer, Endometrial Cancer +4

Start: 2022-09-06End: 2027-10-01Target: 454Updated: 2026-09-23

Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer

RecruitingNCT06954480

Queen Mary University of LondonTriple Negative Breast Cancer

Start: 2025-10-27End: 2030-02-01Target: 140Updated: 2026-05-22

Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer

Not yet recruitingNCT07825753

Fudan UniversityAdvanced or Metastatic Breast Cancer (BC), Advanced or Metastatic Pancreatic Adenocarcinoma

Start: 2026-09-10End: 2030-02-01Target: 225Updated: 2026-09-17

Phase 3

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

RecruitingNCT07291037

AstraZenecaNon-small Cell Lung Cancer (NSCLC)

Start: 2025-10-31End: 2029-01-29Target: 400Updated: 2026-10-13

Phase 4

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.

RecruitingNCT07357597

AstraZenecaStomatitis

Start: 2026-06-24End: 2028-01-04Target: 100Updated: 2026-10-28

Related Papers

TROPION-Urothelial03: A phase 2/3 study of datopotamab deruxtecan (Dato-DXd) + platinum chemotherapy (CT) vs gemcitabine + platinum CT in participants with locally advanced or metastatic urothelial carcinoma (la/mUC) with progression on or after enfortumab vedotin (EV) + pembrolizumab.

Journal of Clinical Oncology2026-05-28

Datopotamab deruxtecan (Dato-DXd) in locally advanced/metastatic urothelial cancer: Updated results from the phase 1 TROPIONPanTumor01 study.

Journal of Clinical Oncology2025-02-1011 citations

TROPION-Breast04: a randomized phase III study of neoadjuvant datopotamab deruxtecan (Dato-DXd) plus durvalumab followed by adjuvant durvalumab versus standard of care in patients with treatment-naïve early-stage triple negative or HR-low/HER2− breast cancer

Therapeutic Advances in Medical Oncology2025-01-0113 citations

TROPION-Breast05: a randomized phase III study of Dato-DXd with or without durvalumab versus chemotherapy plus pembrolizumab in patients with PD-L1-high locally recurrent inoperable or metastatic triple-negative breast cancer

Therapeutic Advances in Medical Oncology2025-01-0110 citations

Datopotamab deruxtecan (Dato-DXd) in Chinese patients (pts) with advanced or metastatic non-small cell lung cancer (NSCLC): Results from the phase 1/2 TROPION-PanTumor02 study.

Journal of Clinical Oncology2024-06-018 citations

Analysis of drug-related interstitial lung disease (ILD) inpatients (pts) treated with datopotamab deruxtecan (Dato-DXd).

Journal of Clinical Oncology2024-06-018 citations

Abstract PO1-20-13: TROPION-Breast04: A phase 3 study of neoadjuvant datopotamab deruxtecan (Dato-DXd) + durvalumab followed by adjuvant durvalumab vs the standard of care in treatment-naive early-stage triple negative or HR-low/HER2– breast cancer

Cancer Research2024-05-026 citations

Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2– and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study

Journal of Clinical Oncology2024-04-23115 citations

Abstract 5618: Evaluating the combination of datopotamab deruxtecan (Dato-DXd) with AZD5305, a highly potent, PARP1-selective inhibitor, -in preclinical models

Cancer Research2024-03-223 citations

Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan.

2024-03-1135 citations

Datopotamab deruxtecan in locally advanced/metastatic urothelial cancer: Preliminary results from the phase 1 TROPION-PanTumor01 study.

Journal of Clinical Oncology2024-01-2913 citations

TROPION-Breast03: a randomized phase III global trial of datopotamab deruxtecan ± durvalumab in patients with triple-negative breast cancer and residual invasive disease at surgical resection after neoadjuvant therapy

Therapeutic Advances in Medical Oncology2024-01-0132 citations

Modulatory Potential of Poly (ADP‐Ribose) Polymerase 1 (PARP1) in BRCA‐Mutated Tumors

European Journal of Cancer Care2024-01-011 citations

Preclinical Characterization of AZD9574, a Blood–Brain Barrier Penetrant Inhibitor of PARP1

Clinical Cancer Research2023-11-1549 citations

TROPION-PanTumor03: Phase 2, multicenter study of datopotamab deruxtecan (Dato-DXd) as monotherapy and in combination with anticancer agents in patients (pts) with advanced/metastatic solid tumors.

Journal of Clinical Oncology2023-06-0120 citations

Abstract CT058: TROPION-PanTumor03: Phase 2, multicenter study of datopotamab deruxtecan (Dato-DXd) as monotherapy and in combination with anticancer agents in patients (pts) with advanced/metastatic solid tumors

Cancer Research2023-04-141 citations

Abstract 2932: Datopotamab deruxtecan (Dato-DXd) enhances antitumor response to PD-1/PD-L1 inhibitors in TROP2-expressing tumors in mice

Cancer Research2023-04-044 citations

Abstract 4893: Evaluation of bystander antitumor effect of Dato-DXd in TROP2 (+) and TROP2 (-) lung cell lines admixed tumor xenograft mouse models

Cancer Research2023-04-041 citations

Abstract P6-10-03: Datopotamab Deruxtecan (Dato-DXd) in Advanced Triple-Negative Breast Cancer (TNBC): Updated Results From the Phase 1 TROPION-PanTumor01 Study

Cancer Research2023-03-0121 citations

Abstract PD13-08: PD13-08 Phase 1 TROPION-PanTumor01 Study Evaluating Datopotamab Deruxtecan (Dato-DXd) in Unresectable or Metastatic Hormone Receptor–Positive/HER2–Negative Breast Cancer (BC)

Cancer Research2023-03-0118 citations

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