patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD) 
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 0 Diseases   8 Trials   8 Trials   181 News 
24 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
2021-005879-40: Phase 3 Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy Estudio en fase III de patritumab deruxtecán frente a quimioterapia basada en platino en el CPNM metastásico o localmente avanzado con EGFRm tras el fracaso del tratamiento con ITC del EGFR

Not yet recruiting
3
560
Europe
Patritumab Deruxtecan, Pemetrexed, Cisplatin, Carboplatin, U3-1402, NA, Powder for solution for infusion, Concentrate for solution for infusion, Solution for infusion, Vitamin B12 1000 µg, Folic Acid, Cisplatin, carboplatin, pemetrexed
Daiichi Sankyo, Inc., DAIICHI SANKYO INC., DAIICHI SANKYO. INC., Daiichi Sankyo, Inc.
Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) Cáncer de pulmón no microcítico (CPNM) metastásico o localmente avanzado con mutación del receptor del factor de crecimiento epidérmico (EGFRm), Non-small Cell Lung Cancer (NSCLC) Cáncer de pulmón no microcítico (CPNM), Diseases [C] - Cancer [C04]
 
 
HERTHENA-Lung02, NCT05338970 / 2021-005879-40: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Active, not recruiting
3
586
Europe, Canada, Japan, US, RoW
Patritumab Deruxtecan, HER3-DXd, U3-1402, Platinum-based chemotherapy
Daiichi Sankyo, Merck Sharp & Dohme LLC
Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR Exon 19 Deletion
05/24
06/26
2020-005722-28: Clinical study to assess the efficacy of U3-1402 in patients with advanced breast cancer with analyzes of biomarkers associated with response to treatment Etude clinique visant à évaluer l’efficacité du U3-1402, chez les patients atteints d’un cancer avancé du sein avec analyses des biomarqueurs associés à la réponse au traitement

Not yet recruiting
2
100
Europe
Patritumab Deruxtecan, U3-1402, Powder for concentrate for solution for injection/infusion
Gustave Roussy, Daiichi-Sankyo
Patients with human epidermal growth factor receptor 3-overexpressing (HER3-high) and hormone-receptor positive (HR+) advanced breast cancer who have already received standard therapy for HR+ advanced breast cancer (ABC), including only one line of chemotherapy for ABC., Patients with advanced breast cancer with hormonal expression and with a high intensity presence of the HER3 receptor on cancer cells and who have already received standard treatment, Diseases [C] - Cancer [C04]
 
 
2022-001181-36: Study of neoadjuvant patritumab deruxtecan with or without endocrine therapy in previously untreated patients – VALENTINE trial Estudio de patritumab deruxtecan neoadyuvante con o sin terapia endocrine en pacientes no tratados previamente – Ensayo VALENTINE

Not yet recruiting
2
120
Europe
patritumab deruxtecan for injection 100mg, U3-1402, Powder for solution for infusion
SOLTI, Daiichi Sankyo Inc.
treatment naïve patients with HR+/HER2-negative high-risk early breast cancer. Pacientes con cáncer de mama temprano de alto riesgo RH+/HER2- no tratadas previamente., Early breast cancer Cancer de mama temprano, Diseases [C] - Cancer [C04]
 
 
ICARUS-BREAST01, NCT04965766 / 2020-005722-28: Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer

Active, not recruiting
2
99
Europe
U3-1402, HER3-DXd
Gustave Roussy, Cancer Campus, Grand Paris, Daiichi Sankyo
Metastatic Breast Cancer, Advanced Breast Cancer
04/25
04/28
HERTHENA-PanTumor01, NCT06172478: A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors

Recruiting
2
400
Europe, Japan, US, RoW
HER3-DXd, Patritumab Deruxtecan, U3-1402
Daiichi Sankyo, Merck Sharp & Dohme LLC
Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer, Ovarian Carcinoma, Cervical Cancer, Endometrial Cancer, Bladder Cancer, Esophageal Cancer, Pancreatic Carcinoma, Prostate Cancer
06/25
04/26
TUXEDO-3, NCT05865990: HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease

Active, not recruiting
2
63
Europe
Patritumab deruxtecan, HER3-DXd
MedSIR, Daiichi Sankyo
Metastatic Breast Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Solid Tumor, Adult
12/25
10/26
HERTHENA-Lung01, NCT04619004 / 2020-000730-17: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

Hourglass Oct 2023 - Oct 2023 : Data from HERTHENA-Lung01 trial for previously treated advanced EGFR-mutated NSCLC at ESMO 2023
Active, not recruiting
2
277
Europe, Japan, US, RoW
Patritumab Deruxtecan (Fixed dose), U3-1402, HER3-DXd, Patritumab Deruxtecan (Up-Titration)
Daiichi Sankyo, Daiichi Sankyo Co., Ltd., Merck Sharp & Dohme LLC
Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
11/22
01/26
NCT06383884: Patritumab Deruxtecan in Patients with Solid Tumor Harboring an NRG1 Fusion

Recruiting
2
30
RoW
Patritumab Deruxtecan, U3-1402
Samsung Medical Center
Solid Tumor, Adult
04/27
04/29
PARAMETer, NCT05620914: A Window of Opportunity Study of Patritumab Deruxtecan in Patients with Brain Metastases

Not yet recruiting
2
15
US
Patritumab deruxtecan
Mustafa Khasraw, MBChB, MD, FRCP, FRACP, Daiichi Sankyo
Brain Metastases, Adult
04/26
04/27
NCT06797635: 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)

Not yet recruiting
2
372
NA
Patritumab deruxtecan, MK-1022, HER3-DXd, U3-1402, Pembrolizumab, MK-3475, KEYTRUDA®, Paclitaxel, TAXOL®, ONXAL®, Carboplatin, PARAPLATIN®, Doxorubicin hydrochloride, ADRIAMYCIN®, Epirubicin hydrochloride, ELLENCE®, Cyclophosphamide, CYTOXAN®, Capecitabine, XELODA®, Olaparib, LYNPARZA®
Merck Sharp & Dohme LLC, Daiichi Sankyo
Breast Neoplasms, Breast Cancer
12/29
12/34
NCT06222489: Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT

Recruiting
2
16
Europe
89Zr-Patritumab deruxtecan, Tracer
The Netherlands Cancer Institute, Daiichi Sankyo
Non-Small Cell Lung Carcinoma, Advanced Non-Small Cell Squamous Lung Cancer, EGFR Gene Mutation
05/27
05/28
KEYMAKER U01, NCT06731907: A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/)

Recruiting
2
90
US
Pembrolizumab, Keytruda®, MK-3475, SCH 900475, Carboplatin, Paraplatin®, Paclitaxel, Taxol, Nab-paclitaxel, Abraxane, Pemetrexed, Alimta, HER3-DXd, patritumab deruxtecan, U3-1402, MK-1022
Merck Sharp & Dohme LLC, Daiichi Sankyo
Non-small Cell Lung Cancer
03/32
03/32
SOLTI VALENTINE, NCT05569811 / 2022-001181-36: NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial

Active, not recruiting
2
120
Europe
Patritumab deruxtecan, Chemotherapy, Letrozole
SOLTI Breast Cancer Research Group, Daiichi Sankyo, Inc.
Breast Cancer
03/25
07/30
NCT04699630: A Study of U3-1402 (Patritumab Deruxtecan) in Subjects with Metastatic Breast Cancer

Active, not recruiting
2
121
US
U3-1402, Patritumab Deruxtecan
SCRI Development Innovations, LLC, Daiichi Sankyo
Metastatic Breast Cancer, Locally Advanced Breast Cancer
11/25
11/25
U31402-A-J101, NCT02980341: Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer

Checkmark Data from trial for HER2 + breast cancer at SABCS 2020
Dec 2020 - Dec 2020: Data from trial for HER2 + breast cancer at SABCS 2020
Completed
1/2
182
Japan, US
Patritumab Deruxtecan, U3-1402
Daiichi Sankyo Co., Ltd., Daiichi Sankyo, Merck Sharp & Dohme LLC
Metastatic Breast Cancer
08/21
09/23
ICARUS-BREAST02, NCT06298084: 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

Recruiting
1/2
152
Europe
Patritumab deruxtecan, U3-1402, HER3-DXd, Olaparib, Lynparza
Gustave Roussy, Cancer Campus, Grand Paris, Daiichi Sankyo
Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer
09/27
06/29
NCT06596694: Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011)

Recruiting
1/2
130
Europe, US, RoW
Patritumab deruxtecan, MK-1022, HER3-DXd, U3-1402
Merck Sharp & Dohme LLC, Daiichi Sankyo
Gastrointestinal Cancer
07/28
07/28
MK-1022-009, NCT06686394: Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed

Recruiting
1/2
81
US, RoW
Patritumab deruxtecan, MK-1022, HER3-DXd, U3-1402, Trastuzumab, Herceptin®, Trastuzumab Biosimilar, Trazimera®, Ogivri®, Herzuma®, Ontruzant®, Kanjinti®, Hercessi®, Pertuzumab, Tucatinib
Merck Sharp & Dohme LLC, Daiichi Sankyo
Breast Neoplasms, Breast Cancer
09/29
09/29
KEYMAKER-U01A, NCT04165070 / 2020-001626-56: 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/)

Hourglass Jan 2022 - Dec 2022 : Of KEYNOTE-01A trial for advanced NSCLC
Recruiting
1/2
450
Europe, US, RoW
Pembrolizumab, MK-3475, SCH 900475, KEYTRUDA®, Carboplatin, PARAPLATIN®, Paclitaxel, ABRAXANE®, Pemetrexed, ALIMTA®, Vibostolimab, MK-7684, Boserolimab, MK-5890, MK-4830, MK-0482, Ifinatamab Deruxtecan (I-DXd), DS-7300a, MK-2400, HER3-DXd, U3-1402, MK-1022
Merck Sharp & Dohme LLC, Daiichi Sankyo
Carcinoma, Non-Small-Cell Lung
02/39
02/39
U31402-A-U102, NCT03260491: U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer

Checkmark Data from trial for NSCLC
Jan 2021 - Jan 2021: Data from trial for NSCLC
Checkmark Data from trial for EGFRm NSCLC at ESMO 2020
Sep 2020 - Sep 2020: Data from trial for EGFRm NSCLC at ESMO 2020
Recruiting
1
309
Europe, Japan, US, RoW
HER3-DXd (FL-DP), U3-1402, HER3-DXd (CTM-1 Lyo-DP), HER3-DXd (CTM-3 Lyo-DP)
Daiichi Sankyo, Merck Sharp & Dohme LLC
Non-Small Cell Lung Cancer (NSCLC)
03/26
12/26
SOLTI TOT-HER3, NCT04610528: A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression

Active, not recruiting
1
80
Europe
U3 1402, Patritumab Deruxtecan
SOLTI Breast Cancer Research Group, Daiichi Sankyo, Inc.
Breast Cancer
01/22
09/23
U31402-A-U103, NCT04676477: 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 recruiting
1
280
Japan, US, RoW
HER3-DXd, U3-1402, Patritumab deruxtecan, Osimertinib
Daiichi Sankyo, AstraZeneca, Merck Sharp & Dohme LLC
Non-Small Cell Lung Cancer (NSCLC)
06/25
02/26
NCT06099639: Medical Access Program for Patritumab Deruxtecan

Available
N/A
US
HER3-DXd, U3-1402
Daiichi Sankyo
Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer
 
 

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