Datopotamab Deruxtecan (Dato-DXd)

DRUG8 trials

Sponsors

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

Conditions

Advanced Solid MalignanciesBiliary Tract CancerBreast Cancer (Locally Advanced or Metastatic)Carcinoma, Non-Small-Cell LungColorectal CancerEndometrial CancerGastric CancerHormone Receptor Positive Breast 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, Triple Negative Breast Cancer, Non-small Cell Lung 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: 2026-08-12

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

AstraZenecaEndometrial Cancer, Gastric Cancer, Metastatic Castration-resistant Prostate Cancer +4

Start: 2022-09-06End: 2027-10-01Target: 454Updated: 2026-08-13

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

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: 2026-09-04

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: 2026-09-03

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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