Patritumab deruxtecan

DRUG20 trials

Sponsors

Medica Scientia Innovation Research S.L., Daiichi Sankyo Inc., Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting, Daiichi Sankyo Co., Ltd., Daiichi Sankyo

Conditions

Advanced Breast CancerAdvanced Non-Small Cell Squamous Lung CancerBrain Metastases, AdultBreast CancerBreast Cancer MetastaticBreast NeoplasmsEGFR Exon 19 DeletionEGFR L858R

Phase 1

Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer

CompletedNCT02980341

Daiichi Sankyo Co., Ltd.Metastatic Breast Cancer

Start: 2016-11-28End: 2023-09-07Updated: 2024-10-30

Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd

RecruitingNCT06298084

Gustave Roussy, Cancer Campus, Grand ParisAdvanced Breast Cancer, Breast Cancer Metastatic, HER2 Low Breast Carcinoma +1

Start: 2024-03-21End: 2029-06-30Target: 152Updated: 2024-03-29

Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)

RecruitingNCT06469944

Merck Sharp & Dohme LLCEsophageal Cancer, Esophageal Neoplasms, Gastroesophageal Adenocarcinoma +1

Start: 2024-09-20End: 2029-09-12Target: 160Updated: 2026-04-02

Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)

RecruitingNCT06596694

Merck Sharp & Dohme LLCGastrointestinal Cancer

Start: 2024-11-03End: 2028-12-07Target: 180Updated: 2026-03-16

Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)

RecruitingNCT06686394

Merck Sharp & Dohme LLCBreast Cancer, Breast Neoplasms

Start: 2025-02-26End: 2030-04-18Target: 81Updated: 2026-02-13

A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)

RecruitingNCT06941272

Merck Sharp & Dohme LLCMalignant Neoplasm

Start: 2025-05-26End: 2030-12-30Target: 50Updated: 2026-03-27

A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

RecruitingNCT07286149

Merck Sharp & Dohme LLCLung Neoplasm Malignant

Start: 2026-03-23End: 2037-05-06Target: 190Updated: 2026-03-16

Phase 2

A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer

TerminatedNCT04479436

Daiichi SankyoMetastatic Colorectal Cancer

Start: 2020-09-14End: 2022-02-03Updated: 2025-05-18

NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial

Active, not recruitingNCT05569811

SOLTI Breast Cancer Research GroupBreast Cancer

Start: 2022-11-25End: 2030-07-31Target: 120Updated: 2023-09-21

A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases

WithdrawnNCT05620914

Mustafa Khasraw, MBChB, MD, FRCP, FRACPBrain Metastases, Adult

Start: 2025-07-31End: 2027-04-30Updated: 2025-06-15

HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease

Active, not recruitingNCT05865990

MedSIRAdvanced Non-Small Cell Squamous Lung Cancer, Metastatic Breast Cancer, Solid Tumor, Adult

Start: 2023-11-24End: 2026-10-01Updated: 2026-03-12

A MULTICENTER, SINGLE-ARM, THREE COHORT, PHASE II TRIAL OF PATRITUMAB DERUXTECAN (HER3-DXD) IN PATIENTS WITH ACTIVE BRAIN METASTASES FROM HER3-EXPRESSING ADVANCED BREAST CANCER AND NON–SMALL CELL LUNG CANCER, AND IN PATIENTS WITH LEPTOMENINGEAL CARCINOMATOSIS FROM HER3-EXPRESSING ADVANCED SOLID TUMORS (The TUXEDO-3 Study)

Active, not recruitingCTIS2023-503251-10-00

Medica Scientia Innovation Research S.L.Metastatic Breast Cancer or Advanced Non-Small Cell Lung Cancer with asymptomatic untreated or progressing Brain Metastases, or solid tumors with Leptomeningeal disease

Start: 2023-10-10Target: 60Updated: 2025-12-03

Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion

RecruitingNCT06383884

Samsung Medical CenterSolid Tumor, Adult

Start: 2024-08-13End: 2029-04-30Target: 30Updated: 2025-12-15

HERTHENA-PanTumor01: A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd) in Subjects with Locally Advanced or Metastatic Solid Tumors

RecruitingCTIS2023-507641-29-00

Daiichi Sankyo Inc.Locally Advanced or Metastatic Solid Tumors

Start: 2024-07-15Target: 373Updated: 2025-11-04

Whole body HER3 quantification with radiolabelled Patritumab deruxtecan (HER3-DXd) PET/CT

RecruitingCTIS2023-508233-14-00

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingEGFR mutation positive advanced stage NSCLC

Start: 2025-03-03Target: 16Updated: 2025-01-13

HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFR mutated Non-Small Cell Lung Cancer (NSCLC)

Active, not recruitingCTIS2024-512238-13-00

Daiichi Sankyo Inc.Metastatic or Locally Advanced EGFR mutated Non-Small Cell Lung Cancer (NSCLC)

Start: 2021-02-10Target: 76Updated: 2025-05-19

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

RecruitingNCT06797635

Merck Sharp & Dohme LLCBreast Cancer, Breast Neoplasms

Start: 2025-03-20End: 2034-12-31Target: 372Updated: 2026-03-13

Phase 3

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Active, not recruitingNCT05338970

Daiichi SankyoEGFR Exon 19 Deletion, EGFR L858R, Nonsquamous Non-small Cell Lung Cancer

Start: 2022-07-08End: 2026-06-30Updated: 2025-01-31

HERTHENA–Lung02: A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy

Active, not recruitingCTIS2023-507964-38-00

Daiichi Sankyo Inc.Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC)

Start: 2022-09-01Target: 183Updated: 2025-07-17

A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

RecruitingNCT07060807

Merck Sharp & Dohme LLCBreast Neoplasms

Start: 2025-07-21End: 2033-07-14Target: 1000Updated: 2026-04-02

Related Papers

Abstract PD13-10: Outcome of patritumab deruxtecan (HER3-DXd) in patients with HER2-positive metastatic breast cancer and CNS involvement previously treated with T-DXd: A subanalysis of TUXEDO-3

Clinical Cancer Research2026-02-17

Abstract PS5-12-21: Herthena-breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2− breast cancer

Clinical Cancer Research2026-02-17

Abstract PS5-12-23: Herthena-breast01: a phase 1b/2, multicenter, open-label, dose-finding study to evaluate the safety and antitumor activity of patritumab deruxtecan (HER3-DXd) in HER2+ unresectable locally advanced or metastatic breast cancer

Clinical Cancer Research2026-02-17

Patritumab deruxtecan (HER3-DXd) in patients with active brain metastases of breast cancer (TUXEDO-3): a multicentre, single-arm, phase 2 trial.

2025-11-011 citations

Patritumab deruxtecan (HER3-DXd) in patients with active brain metastases of non-small-cell lung cancer (TUXEDO-3): a multicentre, single-arm, phase 2 trial.

2025-11-01

HERTHENA-PanTumor01: a phase II study of patritumab deruxtecan (HER3-DXd) in previously treated advanced solid tumors.

2025-10-14

Abstract LB1-06: Primary results of SOLTI VALENTINE: neoadjuvant randomized phase II trial of HER3-DXd alone or in combination with letrozole for high-risk hormone receptor positive (HR+)/HER2-negative (neg) early breast cancer (EBC)

Clinical Cancer Research2025-06-132 citations

Abstract P2-03-25: Characterization of patritumab deruxtecan activity in breast cancer (BC) patient-derived xenograft (PDX) models

Clinical Cancer Research2025-06-13

Patritumab deruxtecan in leptomeningeal metastatic disease of solid tumors: the phase 2 TUXEDO-3 trial

Nature Medicine2025-05-3011 citations

Patritumab deruxtecan (HER3-DXd) in resistant <i>EGFR</i> -mutated ( <i>EGFR</i> m) advanced non-small cell lung cancer (NSCLC) after a third-generation EGFR TKI: The phase 3 HERTHENA-Lung02 study.

Journal of Clinical Oncology2025-05-2816 citations

Patritumab deruxtecan (HER3-DXd) in active brain metastases (BM) from metastatic breast (mBC) and non–small cell lung cancers (aNSCLC), and leptomeningeal disease (LMD) from advanced solid tumors: Results from the TUXEDO-3 phase II trial.

Journal of Clinical Oncology2025-05-282 citations

HERTHENA-Breast03: A phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2− breast cancer.

Journal of Clinical Oncology2025-05-28

Phase 1/2 study of the HER3-directed antibody-drug conjugate patritumab deruxtecan (MK-1022) as monotherapy in patients with gastrointestinal cancers.

Journal of Clinical Oncology2025-01-271 citations

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

Datopotamab Deruxtecan in Advanced or Metastatic Non–Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study

Journal of Clinical Oncology2025-01-0660 citations

Trastuzumab deruxtecan in HER2-positive advanced breast cancer with or without brain metastases: a phase 3b/4 trial.

2024-09-13106 citations

Patritumab deruxtecan (HER3-DXd) in active brain metastases from metastatic breast and non-small cell lung cancers, and leptomeningeal disease from advanced solid tumors: The TUXEDO-3 phase II trial.

Journal of Clinical Oncology2024-06-016 citations

HERTHENA-Lung02: phase III study of patritumab deruxtecan in advanced <i>EGFR</i> -mutated NSCLC after a third-generation EGFR TKI

Future Oncology2023-12-1450 citations

HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in Epidermal Growth Factor Receptor–Mutated Non–Small-Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Platinum-Based Chemotherapy

Journal of Clinical Oncology2023-09-10190 citations

189O A phase II study of patritumab deruxtecan (HER3-DXd), in patients (pts) with advanced breast cancer (ABC), with biomarker analysis to characterize response to therapy (ICARUS-BREAST01)

ESMO Open2023-05-0116 citations

10 more papers not shown