Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06226571 | A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias | PHASE1 | RECRUITING | 76 | — | — | May 21, 2024 | Feb 1, 2027 | Feb 17, 2026 | 46 | United States, Australia +4 |
| 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...