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Therapy Name | ONC201 |
Synonyms | |
Therapy Description |
ONC201 (TIC-10) binds to the G-protein coupled receptor, DRD2, leading to inactivation of AKT and ERK, which relocates Foxo3a to the nucleus and then leads to tumor cell apoptosis mediated by (TNF)-related apoptosis-inducing ligand (TRAIL) signaling (PMID: 23390247) and targets the mitochondrial protease, ClpP (PMID: 31021596, PMID: 31702782, PMID: 31456142). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
ONC201 | TIC-10|TIC10|dordaviprone | Akt Inhibitor (Pan) 21 ERK Inhibitor (pan) 21 | ONC201 (TIC-10) binds to the G-protein coupled receptor, DRD2, leading to inactivation of AKT and ERK, which relocates Foxo3a to the nucleus and then leads to tumor cell apoptosis mediated by (TNF)-related apoptosis-inducing ligand (TRAIL) signaling (PMID: 23390247) and targets the mitochondrial protease, ClpP (PMID: 31021596, PMID: 31702782, PMID: 31456142). |
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 |
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NCT05476939 | Phase III | Everolimus ONC201 | Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 (BIOMEDE 2) | Recruiting | SWE | FRA | ESP | DNK | 0 |
NCT03394027 | Phase II | ONC201 | ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma | Completed | USA | 0 |
NCT03416530 | Phase I | ONC201 | ONC201 in Pediatric H3 K27M Gliomas | Active, not recruiting | USA | 0 |
NCT06012929 | Phase I | ONC201 | A Study of ONC201 for Refractory Meningioma | Not yet recruiting | USA | 0 |
NCT02038699 | Phase Ib/II | ONC201 | A First-in-man Phase I/II Study of Oral ONC201 in Patients With Advanced Cancer | Withdrawn | USA | 0 |
NCT02525692 | Phase II | ONC201 | Oral ONC201 in Recurrent GBM, H3 K27M Glioma, and Midline Glioma | Active, not recruiting | USA | 0 |
NCT02863991 | Phase II | ONC201 | Oral ONC201 in Relapsed/Refractory Multiple Myeloma | Terminated | USA | 0 |
NCT03034200 | Phase II | ONC201 | Phase 2 Study of ONC201 in Neuroendocrine Tumors | Completed | USA | 0 |
NCT05580562 | Phase III | ONC201 | ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study) (ACTION) | Recruiting | USA | NLD | ITA | ISR | GBR | ESP | DNK | DEU | CHE | CAN | AUT | AUS | 3 |
NCT02392572 | Phase Ib/II | ONC201 | ONC201 in Relapsed/Refractory Acute Leukemias and High-risk Myelodysplastic Syndromes (HR-MDS) | Recruiting | USA | 0 |
NCT02420795 | Phase Ib/II | ONC201 | Study of Oral ONC201 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma | Terminated | USA | 0 |
NCT02609230 | Phase I | ONC201 | A Dose-Escalation Study of Onc201 Administered Every One or Three Weeks in Advanced Solid Tumors and Multiple Myeloma | Completed | USA | 0 |
NCT04617002 | Expanded access | ONC201 | Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas | Available | USA | 0 |
NCT02324621 | Phase I | ONC201 | Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors | Completed | USA | 0 |
NCT03733119 | Phase II | ONC201 | ONC201 With and Without Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer | Terminated | USA | 0 |
NCT04629209 | Phase II | ONC201 | A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma | Withdrawn | USA | 0 |
NCT04854044 | Phase I | ONC201 | ONC201 and Radiation Therapy Before Surgery for the Treatment of Recurrent Glioblastoma | Withdrawn | USA | 0 |
NCT03932643 | Phase I | ONC201 | ONC-201 Maintenance Therapy in Acute Myeloid Leukemia and Myelodysplastic Syndrome After Stem Cell Transplant | Active, not recruiting | USA | 0 |
NCT05630794 | Phase I | ONC201 | Testing ONC201 to Prevent Colorectal Cancer | Not yet recruiting | USA | 0 |
NCT03485729 | Phase II | ONC201 | ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer | Active, not recruiting | USA | 0 |
NCT03295396 | Phase II | ONC201 | ONC201 in Adults With Recurrent H3 K27M-mutant Glioma | Active, not recruiting | USA | 0 |
NCT02250781 | Phase I | ONC201 | Akt/ERK Inhibitor ONC201 in Treating Patients With Advanced Solid Tumors | Completed | USA | 0 |
NCT03134131 | Expanded access | ONC201 | Expanded Access Program for ONC201 to Treat Recurrent Histone H3 Mutant Glioma | No longer available | USA | 0 |
NCT03099499 | Phase II | ONC201 | Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer | Terminated | USA | 0 |