marked.bio

HER3 ADC · ADC

patritumab deruxtecan

9 active trials across 5 of our biomarkers, targeting HER3. Not approved for any biomarker on marked.bio yet.

Also known as HER3-DXd, U3-1402.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 5 5 Phase 3
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 2 2 Phase 1/2
KRAS G12C 2 2 Phase 1/2
KRAS G12D 1 1 Phase 1/2
NRG1 fusion 1 1 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of patritumab deruxtecan.

  1. Daiichi Sankyo 5
  2. MSD (Merck & Co.) 1

Trials

9 of 9 trials shown

  1. 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 recruiting Phase 3 Daiichi Sankyo Started 2022Primary completion 2024-05 NCT05338970

    patritumab deruxtecanPlatinum-based chemotherapy

    … documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R at diagnosis or thereafter.

    EGFR exon 19 deletion / L858RNonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR Exon 19 Deletion

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

    Recruiting Phase 1/2 MSD (Merck & Co.) Started 2026Primary completion 2029-08 NCT07286149

    calderasibpatritumab deruxtecansacituzumab tirumotecancetuximabRescue Medications

    …of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations

    KRAS G12CKRAS G12DLung Neoplasm Malignant

  3. A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer

    Recruiting Phase 1/2 Daiichi Sankyo Started 2026Primary completion 2031-01 NCT07701941

    patritumab deruxtecantrastuzumab deruxtecan FDA EU

    Assessed as HER2-low (defined as Immunohistochemistry (IHC)2+/In-situ hybridization (ISH)- or IHC1+) or HER2-u…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Hormone Receptor Positive, HER2-low or HER2-ultralow, Unresectable or Metastatic Breast Cancer

  4. Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT

    Recruiting Phase 2 The Netherlands Cancer Institute Started 2025Primary completion 2027-05 NCT06222489

    patritumab deruxtecan

    Have a histologically or cytologically confirmed diagnosis of (locally) advanced stage EGFR mutation positive NSCLC, not amenable for curative intent treatment.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Carcinoma, Advanced Non-Small Cell Squamous Lung Cancer, EGFR Gene Mutation

  5. Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion

    Recruiting Phase 2 Samsung Medical Center Started 2024Primary completion 2027-04 NCT06383884

    patritumab deruxtecan

    Documentation of NRG1 fusion detected from tumor tissue or blood sample, including but not limited to TruSightOncology…

    NRG1 fusionSolid Tumor, Adult

  6. 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 Phase 1/2 Gustave Roussy, Cancer Campus, Grand Paris Started 2024Primary completion 2027-09 NCT06298084

    patritumab deruxtecanolaparib

    Patients with HER2-low tumors must have been treated with taxanes.

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer

  7. HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

    Active, not recruiting Phase 2 Daiichi Sankyo Started 2021Primary completion 2022-11 NCT04619004

    patritumab deruxtecan

    Documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor

  8. 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 Phase 1 Daiichi Sankyo Started 2021Primary completion 2025-01 NCT04676477

    patritumab deruxtecanosimertinib FDA EU

    Documentation of EGFR exon 19 deletion or L858R mutation detected from tumor tissue

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer (NSCLC)

  9. U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Daiichi Sankyo Started 2017Primary completion 2025-12 NCT03260491

    patritumab deruxtecan

    …with EGFR tyrosine kinase inhibitor (TKI) sensitivity (including G719X, exon 19 deletion, L858R, L861Q)

    EGFR exon 19 deletion / L858RKRAS G12CNon-Small Cell Lung Cancer (NSCLC)