Therapy Detail

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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).

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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).

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  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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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
NCT05630794 Phase I ONC201 Testing ONC201 to Prevent Colorectal Cancer Not yet recruiting USA 0
NCT06012929 Phase I ONC201 A Study of ONC201 for Refractory Meningioma Suspended USA 0
NCT03733119 Phase II ONC201 ONC201 With and Without Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer Terminated 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NCT02038699 Phase Ib/II ONC201 A First-in-man Phase I/II Study of Oral ONC201 in Patients With Advanced Cancer Withdrawn USA 0
NCT03295396 Phase II ONC201 ONC201 in Adults With Recurrent H3 K27M-mutant Glioma Active, not recruiting USA 0
NCT03416530 Phase I ONC201 ONC201 in Pediatric H3 K27M Gliomas Active, not recruiting USA 0
NCT03134131 Expanded access ONC201 Expanded Access Program for ONC201 to Treat Recurrent Histone H3 Mutant Glioma No longer available 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 | BRA | AUT | AUS | ARG 4
NCT05476939 Phase III Everolimus ONC201 Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 (BIOMEDE 2) Recruiting SWE | FRA | ESP | DNK 0
NCT02250781 Phase I ONC201 Akt/ERK Inhibitor ONC201 in Treating Patients With Advanced Solid Tumors Completed USA 0
NCT04629209 Phase II ONC201 A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma Withdrawn USA 0
NCT03099499 Phase II ONC201 Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer Terminated 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
NCT02525692 Phase II ONC201 Oral ONC201 in Recurrent GBM, H3 K27M Glioma, and Midline Glioma Terminated USA 0
NCT03485729 Phase II ONC201 ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer Terminated USA 0
NCT02863991 Phase II ONC201 Oral ONC201 in Relapsed/Refractory Multiple Myeloma Terminated USA 0
NCT02420795 Phase Ib/II ONC201 Study of Oral ONC201 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma Terminated USA 0
NCT03394027 Phase II ONC201 ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma Completed USA 0
NCT02392572 Phase Ib/II ONC201 ONC201 in Relapsed/Refractory Acute Leukemias and High-risk Myelodysplastic Syndromes (HR-MDS) Recruiting USA 0
NCT04854044 Phase I ONC201 ONC201 and Radiation Therapy Before Surgery for the Treatment of Recurrent Glioblastoma Withdrawn 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
NCT02324621 Phase I ONC201 Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors Completed 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


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