Patritumab deruxtecan

Phase 3Antibody–drug conjugate

Merck & Co.

Patritumab deruxtecan is one of 174 biologic programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

173

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerCompleted

Gastrointestinal CancerRecruiting

Malignant NeoplasmRecruiting

Breast NeoplasmsRecruiting

Non Small Cell Lung Cancer MetastaticActive, not recruiting

Solid TumorRecruiting

Hormone Receptor PositiveNot yet recruiting

Lung Neoplasm MalignantRecruiting

Gastroesophageal AdenocarcinomaRecruiting

Non-Small Cell Lung CarcinomaActive, not recruiting

Breast CancerPhase 2

Completed

Gastrointestinal CancerPreclinical

Recruiting

Malignant NeoplasmPreclinical

Recruiting

Breast NeoplasmsPhase 3

Recruiting

Non Small Cell Lung Cancer MetastaticPhase 2

Active, not recruiting

Solid TumorPhase 2

Recruiting

Hormone Receptor PositivePreclinical

Not yet recruiting

Lung Neoplasm MalignantPreclinical

Recruiting

Gastroesophageal AdenocarcinomaPreclinical

Recruiting

Non-Small Cell Lung CarcinomaPhase 3

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Patritumab deruxtecan

Merck & Co.

Phase 3

4 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Duragesic-100

CCephalon

Preclinical

2 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 7

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 8

Tricor

JJagotec

Preclinical

1 9

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

Vfend

PPrism Pharmaceuticals

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Breast Cancer

NCT05865990

Phase 3Active, not recruiting

Non-Small Cell Lung Carcinoma

NCT05338970

Q1 2027

Phase 2Active, not recruiting

Non Small Cell Lung Cancer Metastatic

NCT04619004

Q4 2028

PreclinicalRecruiting

Gastrointestinal Cancer

NCT06596694

Q2 2029

Phase 2Recruiting

Solid Tumor

NCT06383884

PreclinicalRecruiting

Breast Cancer Metastatic

NCT06298084

Clinical

Trials by Indication[1]

Breast Cancer4 trials

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)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT06686394·81 enrolled

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

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1/2·NCT02980341·182 enrolled

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

Active, not recruiting·SSOLTI Breast Cancer Research Group·Phase 2·NCT05569811·120 enrolled

Show 1 more trial

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

Active, not recruiting·MMedSIR·Phase 2·NCT05865990·63 enrolled

Breast Neoplasms2 trials

An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06797635·372 enrolled

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).

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07060807·1,000 enrolled

Metastatic Colorectal Cancer1 trial

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

Terminated· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT04479436·40 enrolled

Brain Metastases1 trial

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

Withdrawn·MMustafa Khasraw, MBChB, MD, FRCP, FRACP·Phase 2·NCT05620914

Solid Tumor1 trial

Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion

Recruiting·SSamsung Medical Center·Phase 2·NCT06383884·30 enrolled

8 more indications

Malignant Neoplasm1 trial

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

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06941272·50 enrolled

Breast Cancer Metastatic1 trial

Phase 1b/2, Multicenter, Open-label, 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·GGustave Roussy, Cancer Campus, Grand Paris·Preclinical·NCT06298084·152 enrolled

Lung Neoplasm Malignant1 trial

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

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT07286149·140 enrolled

Gastroesophageal Adenocarcinoma1 trial

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

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06469944·160 enrolled

Non Small Cell Lung Cancer Metastatic1 trial

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 recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT04619004·277 enrolled

Gastrointestinal Cancer1 trial

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

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06596694·180 enrolled

Non-Small Cell Lung Carcinoma1 trial

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 recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05338970·586 enrolled

Hormone Receptor Positive1 trial

A Phase 1b/2, Multicenter, Open-label, Dose Regimen Determination and Dose Expansion Trial to Evaluate the Safety, Tolerability, Anti-tumor Activity, and an Optimal Dose Regimen of Patritumab Deruxtecan (HER3-DXd) With Trastuzumab Deruxtecan (T-DXd) in Participants With Hormone Receptor Positive, HER2-low or HER2-ultralow, Unresectable or Metastatic Breast Cancer (HERTHENA-Breast02)

Not yet recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Preclinical·NCT07701941·220 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Patritumab deruxtecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Patritumab deruxtecan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Patritumab deruxtecan. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Antibody–drug conjugate[2]
Highest Phase: Phase 3[1]
Company: Merck & Co.

Patritumab deruxtecan

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2028

Q2 2029

Trials by Indication[1]

Breast Cancer4 trials

Breast Neoplasms2 trials

Metastatic Colorectal Cancer1 trial

Brain Metastases1 trial

Solid Tumor1 trial

Malignant Neoplasm1 trial

Breast Cancer Metastatic1 trial

Lung Neoplasm Malignant1 trial

Gastroesophageal Adenocarcinoma1 trial

Non Small Cell Lung Cancer Metastatic1 trial

Gastrointestinal Cancer1 trial

Non-Small Cell Lung Carcinoma1 trial

Hormone Receptor Positive1 trial

References

Drug Info

Quick Facts

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