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Patritumab Deruxtecan

Alternative Names: Patritumab Deruxtecan, U3-1402, U31402, U3 1402, HER3-DXd, MK-1022, MK1022, MK 1022
Latest Update: 2025-04-22
Latest Update Note: Clinical Trial Update

Product Description

Mechanisms of Action: ERBB3 Inhibitor

Novel Mechanism: No

Modality: Antibody Drug Conjugate

Route of Administration: Intravenous

FDA Designation: None *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Daiichi Sankyo
Company Location: TOKYO M0 103-8426
Company CEO:
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Patritumab Deruxtecan

Countries in Clinic: Australia, Austria, Belgium, Bulgaria, Canada, China, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Netherlands, Norway, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 33

Highest Development Phases

Phase 3: Non-Small-Cell Lung Cancer|Squamous Cell Carcinoma

Phase 2: Biliary Tract Cancer|Bladder Cancer|Brain Cancer|Breast Cancer|Cervical Cancer|Colorectal Cancer|Endometrial Cancer|Esophageal Cancer|Gastrointestinal Cancer|Head and Neck Cancer|Hepatocellular Carcinoma|Melanoma|Meningeal Cancer|Oncology Solid Tumor Unspecified|Ovarian Cancer|Pancreatic Cancer|Prostate Cancer|Spinal Cord Cancer|Triple Negative Breast Cancer|Uterine Cancer

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
MK-1022-010

P2

Not yet recruiting

Triple Negative Breast Cancer

2034-11-26

HERTHENA-Breast03

P2

Not yet recruiting

Breast Cancer

2029-12-31

VALENTINE

P2

Active, not recruiting

Breast Cancer

2029-11-17

SOLTI-2103

P2

Unknown Status

Breast Cancer

2029-10-17

Recent News Events

Date

Type

Title

04/21/2025

News Article

 ENHERTU® Plus Pertuzumab Demonstrated Highly Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival Versus THP as First-Line Therapy for Patients with HER2 Positive Metastatic Breast Cancer

03/31/2025

News Article

 DESTINY-Gastric05 Phase 3 Trial of ENHERTU® Initiated in Patients with Previously Untreated HER2 Positive Advanced Gastric Cancer

01/31/2025

News Article

 TROPION-Lung12 Phase 3 Trial Initiated Evaluating DATROWAY® as Part of Adjuvant Regimen for Patients with Early-Stage Non-Small Cell Lung Cancer at High Risk of Relapse

01/27/2025

News Article

 ENHERTU® Approved in the U.S. as First HER2 Directed Therapy for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following Disease Progression After One or More Endocrine Therapies

05/01/2024

PubMed

 Translational insights and overall survival in the U31402-A-U102 study of patritumab deruxtecan (HER3-DXd) in EGFR-mutated NSCLC.

04/20/2024

PubMed

 Antibody-drug conjugates in lung and breast cancer: Current evidence and future directions - a position statement from the ETOP IBCSG Partners Foundation.

04/17/2024

PubMed

 DB-1310, an ADC comprised of a novel anti-HER3 antibody conjugated to a DNA topoisomerase I inhibitor, is highly effective for the treatment of HER3-positive solid tumors.

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