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Therapy Name Patritumab deruxtecan
Synonyms
Therapy Description

Patritumab deruxtecan (U3-1402) is an antibody-drug conjugate (ADC) comprising an ERBB3 (HER3) antibody and Exatecan, which once internalized may result in apoptotic cell death (PMID: 31395690, PMID: 31661465, PMID: 31471314).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Patritumab deruxtecan U3-1402|HER3-DXd|U3 1402|U31402 HER3 (ERBB3) Antibody 23 Patritumab deruxtecan (U3-1402) is an antibody-drug conjugate (ADC) comprising an ERBB3 (HER3) antibody and Exatecan, which once internalized may result in apoptotic cell death (PMID: 31395690, PMID: 31661465, PMID: 31471314).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04699630 Phase II Patritumab deruxtecan A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer Recruiting USA 0
NCT06172478 Phase II Patritumab deruxtecan A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors Recruiting USA 1
NCT04619004 Phase II Patritumab deruxtecan HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS 6
NCT04965766 Phase II Patritumab deruxtecan Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (ICARUS-BREAST) Recruiting FRA 0
NCT05620914 Phase I Patritumab deruxtecan A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases (PARAMETer) Not yet recruiting USA 0
NCT05569811 Phase II Letrozole + Patritumab deruxtecan Patritumab deruxtecan NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial (VALENTINE) Active, not recruiting ESP 0
NCT06099639 Expanded access Patritumab deruxtecan Medical Access Program for Patritumab Deruxtecan Available USA 0
NCT06298084 Phase Ib/II Patritumab deruxtecan Olaparib + Patritumab deruxtecan 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 (ICARUSBREAST02) Recruiting FRA 0
NCT02980341 Phase Ib/II Patritumab deruxtecan Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer Completed USA 1
NCT04479436 Phase II Patritumab deruxtecan A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer Terminated USA | ITA | GBR | FRA | ESP | BEL 2
NCT05865990 Phase II Patritumab deruxtecan HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease (TUXEDO-3) Recruiting ESP | AUT 0
NCT03260491 Phase I Patritumab deruxtecan U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer Recruiting USA | NLD | ESP 3
NCT04676477 Phase I Patritumab deruxtecan Osimertinib + Patritumab deruxtecan HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer Recruiting USA 3
NCT04610528 Phase I Patritumab deruxtecan A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression (TOT-HER3) Active, not recruiting ESP 0
NCT05338970 Phase III Patritumab deruxtecan 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 USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 10


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