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Therapy Name | PQR309 |
Synonyms | |
Therapy Description |
PQR309 (bimiralisib) is a dual pan-PI3K and mTORC1/2 inhibitor, which blocks PI3K/mTOR signaling, potentially resulting in inhibition of tumor growth (PMID: 29066507). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
PQR309 | PQR 309|PQR-309|Bimiralisib | mTOR Inhibitor 51 PI3K Inhibitor (Pan) 38 | PQR309 (Bimiralisib) is a dual pan-PI3K and mTORC1/2 inhibitor, which blocks PI3K/mTOR signaling, potentially resulting in inhibition of tumor growth (PMID: 29066507). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
Unknown unknown | Advanced Solid Tumor | not applicable | PQR309 | Phase I | Actionable | In a Phase I trial, PQR309 demonstrated safety and preliminary efficacy in patients with advanced solid tumors (J Clin Oncol 34, 2016 (suppl; abstr 2560)). | detail... |
Unknown unknown | lymphoma | not applicable | PQR309 | Preclinical - Cell culture | Actionable | In a preclinical study, PQR309 inhibited proliferation of lymphoma cells in culture, which was found to be due to the induction cell cycle arrest (PMID: 29066507). | 29066507 |
NOTCH1 C478F | head and neck squamous cell carcinoma | predicted - sensitive | PQR309 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, head and neck squamous cell carcinoma xenograft models harboring NOTCH1 C478F demonstrated reduced tumor size when treated with PQR309 (bimiralisib) (PMID: 30770351). | 30770351 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03740100 | Phase II | PQR309 | Single-arm Study With Bimiralisib in Patients With HNSCC Harboring NOTCH1 Loss of Function Mutations (HNSCC) | Recruiting | USA | 0 |
NCT02249429 | Phase Ib/II | PQR309 | Open-Label, Non Randomized Phase 2 Study With Safety Run-In | Completed | USA | 5 |
NCT02483858 | Phase I | PQR309 | Study of Oral PQR309 in Patients With Advanced Solid Tumors | Completed | USA | 0 |
NCT02669511 | Phase II | PQR309 | PQR309 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma | Completed | 0 |