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| Therapy Name | ARX-788 |
| Synonyms | |
| Therapy Description |
ARX-788 is an antibody-drug conjugate (ADC) comprising a dolastatin analog and an antibody specific to ERBB2 (HER2), which may result in cell death and tumor regression (Cancer Res 2015;75(15 Suppl):Abstract nr 639, PMID: 30841523, PMID: 32669315). |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| ARX-788 | ARX788|ARX 788 | HER2 (ERBB2) Antibody 79 HER2 (ERBB2) Antibody-Drug Conjugate 35 | ARX-788 is an antibody-drug conjugate (ADC) comprising a dolastatin analog and an antibody specific to ERBB2 (HER2), which may result in cell death and tumor regression (Cancer Res 2015;75(15 Suppl):Abstract nr 639, PMID: 30841523, PMID: 32669315). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03255070 | Phase I | ARX-788 | A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01) | Completed | USA | AUS | 0 |
| NCT05041972 | Phase II | ARX-788 | ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02) | Withdrawn | USA | 0 |
| NCT04829604 | Phase II | ARX-788 | ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03) | Active, not recruiting | USA | AUS | 1 |
| NCT06224673 | Phase II | ARX-788 | ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer | Not yet recruiting | USA | 0 |
| NCT01042379 | Phase II | GSK5733584 Zanidatamab Cemiplimab + VSV-hIFNbeta-NIS Cyclophosphamide + Doxorubicin + Paclitaxel + Trastuzumab ARX-788 Letrozole + Vepdegestrant Lasofoxifene Datopotamab deruxtecan + Durvalumab Abemaciclib + Vepdegestrant Dostarlimab-gxly + GSK5733584 Cemiplimab + Paclitaxel + Sarilumab Abemaciclib + Z-endoxifen HCl DAN-222 + Niraparib Datopotamab deruxtecan Vepdegestrant AZD2936 + Trastuzumab deruxtecan Z-endoxifen HCl | I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY) | Recruiting | USA | 0 |