Therapy Detail
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| Therapy Name | Zanidatamab |
| Synonyms | |
| Therapy Description |
Ziihera (zanidatamab) is a bispecific antibody targeting ERBB2 (HER2), which induces anti-tumor immune response against Erbb2 (Her2)-expressing tumors (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 255P, PMID: 32054397). Ziihera (zanidatamab) is FDA-approved for use in patients with unresectable or metastatic ERBB2 (HER2)-positive (IHC 3+) biliary tract cancer (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Zanidatamab | Ziihera | ZW-25|ZW25|Zanidatamab-hrii | HER2 (ERBB2) Antibody 79 | Ziihera (zanidatamab) is a bispecific antibody targeting ERBB2 (HER2), which induces anti-tumor immune response against Erbb2 (Her2)-expressing tumors (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 255P, PMID: 32054397). Ziihera (zanidatamab) is FDA-approved for use in patients with unresectable or metastatic ERBB2 (HER2)-positive (IHC 3+) biliary tract cancer (FDA.gov). |
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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 |
|---|---|---|---|---|---|---|
| NCT07192068 | Phase II | Zanidatamab | Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene. (AcSe HER2) | Active, not recruiting | FRA | 0 |
| NCT06695845 | Phase II | Zanidatamab | A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors | Recruiting | USA | 1 |
| NCT04578444 | Expanded access | Zanidatamab | An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer | No longer available | USA | ITA | GBR | FRA | ESP | 0 |
| NCT02892123 | Phase I | Capecitabine + Zanidatamab Zanidatamab Paclitaxel + Zanidatamab Vinorelbine + Zanidatamab | Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers | Completed | USA | CAN | 1 |
| NCT04513665 | Phase II | Zanidatamab | ZW25 in Women With Endometrial Cancers | Completed | USA | 0 |
| NCT05615818 | Phase III | Niraparib Zanidatamab Binimetinib + Encorafenib Futibatinib Cisplatin + Gemcitabine Neratinib + Trastuzumab Ivosidenib | Personalized Medicine for Advanced Biliary Cancer Patients (SAFIR-ABC10) | Recruiting | GBR | FRA | BEL | 0 |
| NCT04466891 | Phase II | Zanidatamab | A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers (HERIZON-BTC-01) | Completed | USA | ITA | GBR | FRA | ESP | CAN | 3 |
| NCT05035836 | Phase II | Letrozole + Zanidatamab Zanidatamab Tamoxifen + Zanidatamab | A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) | 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 |
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