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SNDX-5613 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SNDX-5613 | EXPERIMENTAL | Dose Escalation: * Induction: Sequential cohorts of escalating dose levels of SNDX-5613 with chemotherapy regimen. * Consolidation: Cohorts will receive high-dose cytarabine (HiDAC) chemotherapy followed by SNDX-5613. * Maintenance Monotherapy: Cohorts will receive SNDX-5613. Dose Expansion: * Induction: SNDX-5613 at tolerated dose level with chemotherapy regimen. * Consolidation: Cohorts will receive SNDX-5613 with chemotherapy regimen and HiDAC. * Maintenance Monotherapy: Cohorts will receive SNDX-5613. |
| Name | Type | Description |
|---|---|---|
| SNDX-5613 | DRUG | Participants will receive SNDX-5613 orally during Induction, Consolidation, and Maintenance until meeting criteria for discontinuation. |
| Chemotherapy Regimen | DRUG | Induction: Participants will receive an intravenous (IV), 2-drug combination of cytarabine and either daunorubicin or idarubicin. |
| HiDAC | DRUG | Consolidation: Participants will receive HiDAC IV. |
Inclusion Criteria: * Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria. * Previously untreated AML and eligible to receive intensive chemotherapy. * KMT2Ar, NPM1c, or NUP98r mutations identified by local laboratory prior to the first dose of SNDX-561...
SNDX-5613 is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemias. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in combination with intensive chemotherapy in patients with this hematologic malignancy.
SNDX-5613 targets menin, a protein involved in gene regulation. By inhibiting menin, the drug aims to disrupt pathways that drive the growth of Acute Myeloid Leukemia cells. This targeted approach is being investigated in a Phase 1 clinical trial for patients with this disease.
SNDX-5613 is being developed by Syndax Pharmaceuticals, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol SNDX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with Acute Myeloid Leukemias.
SNDX-5613 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is evaluating the drug in combination with intensive chemotherapy for patients with Acute Myeloid Leukemias.
SNDX-5613 is being studied in a Phase 1 clinical trial with the identifier NCT06226571. This trial, titled 'A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias,' is active but not recruiting. It has an enrollment of 76 participants and is being conducted in the United States, Australia, Canada, Netherlands, Spain, and the United Kingdom.