Therapy Detail
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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 28 | 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 |
|---|---|---|---|---|---|---|
| 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 | BGR | BEL | AUT | AUS | 5 |
| 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 |
| 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 | POL | NOR | NLD | ITA | GBR | FRA | ESP | DEU | CHE | CAN | BEL | AUT | AUS | 7 |
| NCT05865990 | Phase II | Patritumab deruxtecan | HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease (TUXEDO-3) | Active, not recruiting | ESP | AUT | 0 |
| 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) | Unknown status | ESP | 0 |
| NCT06099639 | Expanded access | Patritumab deruxtecan | Medical Access Program for Patritumab Deruxtecan | No longer available | USA | 0 |
| NCT04699630 | Phase II | Patritumab deruxtecan | A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer | Completed | USA | 0 |
| NCT07060807 | Phase III | Nab-paclitaxel Paclitaxel Trastuzumab deruxtecan Patritumab deruxtecan Pegylated liposomal doxorubicin Capecitabine | A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) | Recruiting | USA | TUR | POL | ITA | ISR | HUN | GRC | FRA | ESP | ARG | 5 |
| NCT06941272 | Phase Ib/II | Patritumab deruxtecan | A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01) | Recruiting | USA | SWE | SVK | NLD | ISR | GBR | FRA | ESP | DNK | BEL | 2 |
| NCT04479436 | Phase II | Patritumab deruxtecan | A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer | Terminated | USA | POL | ITA | GBR | FRA | ESP | BEL | 1 |
| NCT06172478 | Phase II | Patritumab deruxtecan | A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors | Recruiting | USA | NOR | NLD | ITA | HUN | GBR | FRA | ESP | CAN | BEL | AUS | 3 |
| 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 |
| NCT06596694 | Phase Ib/II | Patritumab deruxtecan | Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02) | Recruiting | USA | TUR | NZL | ITA | ISR | FRA | ESP | CHE | CAN | AUS | 5 |
| NCT04965766 | Phase II | Patritumab deruxtecan | Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (ICARUS BREAST) | Active, not 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 |
| NCT03260491 | Phase I | Patritumab deruxtecan | U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer | Recruiting | USA | NLD | ESP | 3 |
| NCT05620914 | Phase I | Patritumab deruxtecan | A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases (PARAMETer) | Withdrawn | USA | 0 |
| 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 | Active, not recruiting | USA | 3 |
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