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T-DXd

DRUG9 trials

Sponsors

AstraZeneca, Daiichi Sankyo, Beijing 302 Hospital, Fudan University, SOLTI Breast Cancer Research Group

Conditions

Advanced CancerAdvanced Solid TumorBreast CancerBreast Cancer Stage IVHER2-positive Breast CancerLocally Advanced or Metastatic Non-Small Cell Lung CancerMetastatic Cancer

Phase 1

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC
RecruitingNCT04686305
AstraZenecaLocally Advanced or Metastatic Non-Small Cell Lung Cancer
Start: 2021-03-09End: 2027-06-30Target: 244Updated: 2025-11-13
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Active, not recruitingNCT05765851
Daiichi SankyoAdvanced Solid Tumor, Breast Cancer
Start: 2023-05-30End: 2026-06-30Target: 78Updated: 2025-05-11
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
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
RecruitingNCT07134153
Fudan UniversityBreast Cancer
Start: 2025-04-18End: 2027-02-28Target: 139Updated: 2025-08-21

Phase 2

T-DXd Versus THP for Medium-risk HER2-positive Early Breast Cancer
Not yet recruitingNCT06548178
Fudan UniversityHER2-positive Breast Cancer
Start: 2024-09-30End: 2028-09-30Target: 242Updated: 2024-08-12
Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
RecruitingNCT07371585
SOLTI Breast Cancer Research GroupBreast Cancer Stage IV
Start: 2026-02-18End: 2030-07-01Target: 300Updated: 2026-03-27
SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study
Not yet recruitingNCT07417241
Peking University Cancer Hospital & InstituteBreast Cancer, HER2-positive Breast Cancer
Start: 2026-03-31End: 2029-12-31Target: 100Updated: 2026-02-18

Phase 3

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
RecruitingNCT06174987
Daiichi SankyoAdvanced Cancer, Metastatic Cancer
Start: 2024-01-05End: 2028-01-17Target: 50Updated: 2025-10-15

Unknown Phase

Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib
NCT06135194
Beijing 302 HospitalBreast Cancer
Start: 2021-04-01End: 2024-06-30Target: 30Updated: 2023-11-18

Related Papers

Trastuzumab Deruxtecan in Patients With HER2-Overexpressing NSCLC: Results From Part 1 of the Open-Label, Multicenter, Phase 1b DESTINY-Lung03 Trial.
2025-12-23
Abstract P3-08-24: Valemetostat and Trastuzumab Deruxtecan in Patients With HER2-Low, Previously Treated, Unresectable or Metastatic Breast Cancer
Clinical Cancer Research2025-06-13
Abstract 3790: Preclinical assessment of valemetostat, a dual inhibitor of EZH2 and EZH1, combined with trastuzumab deruxtecan and datopotamab deruxtecan for multiple solid tumors
Cancer Research2025-04-21
Valemetostat and trastuzumab deruxtecan (T-DXd) in previously treated advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric cancer or gastro-esophageal junction (GEJ) adenocarcinoma.
Journal of Clinical Oncology2025-01-27
A phase 1b, multicenter, open-label study of valemetostat in combination with DXd antibody drug conjugates (ADCs), trastuzumab deruxtecan (T-DXd) or datopotamab deruxtecan (Dato-DXd), in patients with solid tumors.
Journal of Clinical Oncology2024-06-017 citations
Abstract CT572: Phase 1b dose-escalation and dose-expansion study evaluating trastuzumab deruxtecan (T-DXd) in combination with durvalumab and cisplatin, carboplatin, or pemetrexed in advanced or metastatic, HER2-overexpressing, nonsquamous non-small cell lung cancer (NSCLC): DESTINY-Lung03
Cancer Research2022-06-151 citations