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Therapy Detail
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| Therapy Name | CYC065 |
| Synonyms | |
| Therapy Description |
CYC065 (Fadraciclib) inhibits CDK2, CDK5, and CDK9, potentially resulting in decreased tumor cell growth (PMID: 28376145, PMID: 27351214, PMID: 32645016). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| CYC065 | Fadraciclib|CYC-065|CYC 065 | CDK2 Inhibitor 31 CDK5 Inhibitor 8 CDK9 Inhibitor 21 | CYC065 (Fadraciclib) inhibits CDK2, CDK5, and CDK9, potentially resulting in decreased tumor cell growth (PMID: 28376145, PMID: 27351214, PMID: 32645016). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| KMT2A rearrange | acute lymphoblastic leukemia | predicted - sensitive | CYC065 | Preclinical - Cell culture | Actionable | In a preclinical study, acute lymphoblastic leukemia cell lines harboring KMT2A rearrangements were sensitive to treatment with CYC065 (Fadraciclib) in culture (PMID: 32645016). | 32645016 |
| KMT2A rearrange | acute myeloid leukemia | sensitive | CYC065 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, CYC065 (Fadraciclib) treatment resulted in decreased cell viability in an acute myeloid leukemia cell line harboring a KMT2A rearrangement in culture and inhibited tumor growth in a cell line xenograft model (PMID: 32645016). | 32645016 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05168904 | Phase Ib/II | CYC065 | A Study to Investigate Fadraciclib (CYC065), in Subjects With Leukemia or Myelodysplastic Syndrome (MDS) | Suspended | USA | 0 |
| NCT02552953 | Phase I | CYC065 | A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers | Completed | USA | 0 |
| NCT04983810 | Phase Ib/II | CYC065 | A Study to Investigate Fadraciclib (CYC065), in Subjects With Advanced Solid Tumors and Lymphoma | Recruiting | USA | ESP | 1 |
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