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HER3-DXd

BIOLOGICAL6 trials

Sponsors

Merck Sharp & Dohme LLC, Daiichi Sankyo

Conditions

Advanced Solid TumorBladder CancerBreast CancerCarcinoma, Non-Small-Cell LungCervical CancerEndometrial CancerEpidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung CancerEsophageal Cancer

Phase 1

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
RecruitingNCT04165070
Merck Sharp & Dohme LLCCarcinoma, Non-Small-Cell Lung
Start: 2019-12-19End: 2032-02-13Target: 450Updated: 2026-03-16
HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer
Active, not recruitingNCT04676477
Daiichi SankyoNon-Small Cell Lung Cancer (NSCLC)
Start: 2021-06-11End: 2027-04-30Updated: 2025-06-22
Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)
RecruitingNCT06445972
Merck Sharp & Dohme LLCEsophageal Cancer, Esophageal Neoplasms, Gastroesophageal Adenocarcinoma +1
Start: 2024-08-07End: 2030-08-08Target: 210Updated: 2026-04-02

Phase 2

A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
RecruitingNCT06172478
Daiichi SankyoAdvanced Solid Tumor, Bladder Cancer, Breast Cancer +11
Start: 2024-02-26End: 2028-10-10Target: 740Updated: 2026-01-28
A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)
RecruitingNCT06731907
Merck Sharp & Dohme LLCNon-small Cell Lung Cancer
Start: 2025-03-30End: 2032-03-12Target: 90Updated: 2026-02-18

Unknown Phase

Medical Access Program for Patritumab Deruxtecan
NCT06099639
Daiichi SankyoEpidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer
Updated: 2025-06-08

Related Papers

HERTHENA-PanTumor01: a phase II study of patritumab deruxtecan (HER3-DXd) in previously treated advanced solid tumors.
2025-10-14
KEYMAKER-U01 substudy 01A: Phase 1/2 study of pembrolizumab plus ifinatamab deruxtecan (I-DXd) or patritumab deruxtecan (HER3-DXd) with or without chemotherapy in untreated stage IV non–small-cell lung cancer.
Journal of Clinical Oncology2025-05-28
KEYMAKER-U06: Phase 1/2 umbrella platform study of TROP2 antibody-drug conjugate sacituzumab tirumotecan plus pembrolizumab plus chemotherapy (substudy 06C) and sacituzumab tirumotecan plus paclitaxel (substudy 06D) in gastroesophageal adenocarcinoma.
Journal of Clinical Oncology2025-01-27
HER3 is widely expressed across diverse subtypes of NSCLC in a retrospective analysis of archived tissue samples
Future Oncology2024-09-252 citations
HERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors.
Journal of Clinical Oncology2024-06-012 citations
Phase 1 study of patritumab deruxtecan (HER3-DXd; U3-1402) in combination with osimertinib in patients with advanced <i>EGFR</i>-mutated NSCLC.
Journal of Clinical Oncology2022-06-017 citations
Dynamics of HER3 and its correlated gene expression profile in EGFR-mutated NSCLC tumor treated with EGFR-TKI toward enhancing effectiveness of patritumab deruxtecan (HER3-DXd; U3-1402).
Journal of Clinical Oncology2022-06-011 citations