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Therapy Name | SNDX-5613 |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
SNDX-5613 | SNDX5613|SNDX 5613 | MEN1-KMT2A Inhibitor 5 | SNDX-5613 binds to Menin and inhibits its interaction with MLL, potentially resulting in decreased proliferation of tumor cells with MLL rearrangements (NCI Drug Dictionary). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
KMT2A rearrange | acute leukemia | predicted - sensitive | SNDX-5613 | Phase I | Actionable | In a Phase I trial (AUGMENT 101), SNDX-5613 treatment demonstrated acceptable safety and promising antileukemic activity in patients with acute leukemia harboring KMT2A rearrangements, and led to a composite complete response rate of 49% (17/35) (Blood (2021) 138 (Supplement 1): 699). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04065399 | Phase Ib/II | SNDX-5613 | A Study of SNDX-5613 in R/R Leukemias Including Those With an MLLr/KMT2A Gene Rearrangement or NPM1 Mutation (AUGMENT-101) | Recruiting | USA | CAN | 1 |
NCT05406817 | Phase I | SNDX-5613 | Study of Radiolabeled SNDX-5613 in Adults With Acute Myeloid Leukemia | Not yet recruiting | USA | 0 |
NCT05326516 | Phase I | SNDX-5613 | A Study of SNDX-5613 in Combination With Chemotherapy in Participants With Leukemia | Recruiting | USA | 0 |
NCT05360160 | Phase Ib/II | Decitabine and Cedazuridine SNDX-5613 Venetoclax | A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE) | Not yet recruiting | USA | 0 |