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Therapy Name | Nab-rapamycin |
Synonyms | |
Therapy Description |
Fyarro (nab-rapamycin) is nanoparticle albumin-bound rapamycin and inhibitor of mTOR that has immunosuppressant and anti-tumor activities (PMID: 24089446). Fyarro (nab-rapamycin) is FDA approved for use in patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Nab-rapamycin | Fyarro | ABI-009|nab-sirolimus | mTORC1 Inhibitor 9 | Fyarro (nab-rapamycin) is nanoparticle albumin-bound rapamycin and inhibitor of mTOR that has immunosuppressant and anti-tumor activities (PMID: 24089446). Fyarro (nab-rapamycin) is FDA approved for use in patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
TSC2 inact mut | perivascular epithelioid cell tumor | predicted - sensitive | Nab-rapamycin | Phase II | Actionable | In a Phase II trial (AMPECT), Fyarro (nab-rapamycin) treatment in patients with perivascular epithelioid cell tumors (PEComas) resulted in partial response in 20% (1/5) of patients with TSC1 mutations, 89% (8/9) of patients with TSC2 mutations, and 9% (1/11) of patients without a TSC1 or TSC2 mutation (PMID: 34637337; NCT02494570). | 34637337 |
TSC2 inact mut | Advanced Solid Tumor | predicted - sensitive | Nab-rapamycin | Clinical Study | Actionable | In a clinical study, Fyarro (nab-rapamycin) treatment in patients with advanced solid tumors harboring mutations in TSC1 or TSC2 led to a partial response in 4 patients, stable disease in 2 patients and progressive disease in 1 patient of 7 enrolled patients (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 3111-3111; NCT03817515). | detail... |
TSC1 inact mut | perivascular epithelioid cell tumor | predicted - sensitive | Nab-rapamycin | Phase II | Actionable | In a Phase II trial (AMPECT), Fyarro (nab-rapamycin) treatment in patients with perivascular epithelioid cell tumors (PEComas) resulted in partial response in 20% (1/5) of patients with TSC1 mutations, 89% (8/9) of patients with TSC2 mutations, and 9% (1/11) of patients without a TSC1 or TSC2 mutation (PMID: 34637337; NCT02494570). | 34637337 |
TSC1 inact mut | Advanced Solid Tumor | predicted - sensitive | Nab-rapamycin | Clinical Study | Actionable | In a clinical study, Fyarro (nab-rapamycin) treatment in patients with advanced solid tumors harboring mutations in TSC1 or TSC2 led to a partial response in 4 patients, stable disease in 2 patients, and progressive disease in 1 patient of 7 enrolled patients (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 3111-3111; NCT03817515). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT05661461 | Phase I | Nab-rapamycin | Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment | Recruiting | USA | 0 |
NCT05103358 | Phase II | Nab-rapamycin | Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1) | Active, not recruiting | USA | 2 |
NCT02494570 | Phase II | Nab-rapamycin | A Phase 2 Study of ABI-009 in Patients With Advanced Malignant PEComa | Completed | USA | 0 |
NCT05997017 | Phase II | Nab-rapamycin | Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer | Recruiting | USA | 0 |
NCT05997056 | Phase II | Nab-rapamycin | Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors | Recruiting | USA | 0 |
NCT02646319 | Phase I | Nab-rapamycin | Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations | Completed | USA | 0 |
NCT03670030 | Phase II | Nab-rapamycin | A Study to Test the Effectiveness of ABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System | Terminated | USA | 0 |
NCT03463265 | Phase II | Lomustine + Nab-rapamycin Nab-rapamycin Nab-rapamycin + Temozolomide Bevacizumab + Nab-rapamycin | ABI-009 (Nab-Rapamycin) in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma | Completed | USA | 0 |