Drug

Patritumab deruxtecan

In clinical development

ClassDNA topoisomerase I inhibitorEmerging researchLate-stage development

Also known as HER3-DXd, Anti-her3 antibody-drug conjugate u3 1402.

RxNorm2703535 ChEMBLCHEMBL4594611 ATCL01FX36UNII3XPI7EG4W8

Research papers

Active clinical trials

Protein targets

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04).

Clinical trial2026-07-30Results expected Q3 2033 · ClinicalTrials.gov

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)

Clinical trial2026-07-17Results posted · ClinicalTrials.gov

LIGHTBEAM-U01 Substudy 01C: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Clinical trial2026-07-17Results expected Q4 2030 · ClinicalTrials.gov

A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

Clinical trial2026-07-06Results expected Q2 2028 · ClinicalTrials.gov

A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers

Clinical trial2026-06-29Results expected Q4 2028 · ClinicalTrials.gov

KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

Clinical trial2026-06-23Results expected Q1 2032 · ClinicalTrials.gov

KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Clinical trial2026-06-18Results expected Q3 2031 · ClinicalTrials.gov

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

Clinical trial2026-05-26Results expected Q3 2029 · ClinicalTrials.gov

KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

Clinical trial2026-05-26Results expected Q1 2032 · ClinicalTrials.gov

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

Research2025-05-30Nature medicine

Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3-Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3-Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II Trial.

Research2023-10-06Journal of clinical oncology : official journal of the American Society of Clinical Oncology

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.

Research2023-09-10Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Patritumab deruxtecan

Aliases & brands

HER3-DXdAnti-her3 antibody-drug conjugate u3 1402

RxNorm CUI

2703535

ChEMBL ID

CHEMBL4594611

ATC codes

L01FX36

UNII

3XPI7EG4W8

Primary mechanism

DNA topoisomerase I inhibitor

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

DNA topoisomerase 1

TOP1 · P11387

INHIBITORDNA topoisomerase I inhibitor

Receptor tyrosine-protein kinase erbB-3

ERBB3 · P21860

BINDING AGENTReceptor tyrosine-protein kinase erbB-3 binding agent

Clinical trials

22 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 22

Phase 12Phase 1 / 29Phase 29Phase 32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

RecruitingPH IIIKey trialMerck Sharp & Dohme LLCn=1,0002033

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 (HERTHENA-Lung02)

Active, not recruitingPH IIIDaiichi Sankyon=5862026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Multicenter, Single-arm, 3 Cohort, Phase II Trial of HER3-DXd in Patients With Active Brain Metastases From Metastatic Breast Cancer and Non-small Cell Lung Cancer, and in Patients With Leptomeningeal Disease From Advanced Solid Tumors

CompletedPH IIMedSIRn=632026

Phase 1/2, Multicenter, Open-label, Multiple-Dose First-in-human Study of U3-1402, in Subjects With HER3 Positive Metastatic Breast Cancer

CompletedPH I/IIDaiichi Sankyo Co., Ltd.n=1822023

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20232025

Most influential

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 188 cites

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 102 cites

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

Nature medicine · 2025 · 16 cites

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Breast Neoplasms2 Lung Neoplasms2

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Camptothecin

Studied across 4 of the same disease areas as Patritumab deruxtecan in the shared literature.

4 shared diseases2 shared papers

Platinum

Studied across 3 of the same disease areas as Patritumab deruxtecan in the shared literature.

3 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials