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Emavusertib
Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Ensayo de CURIS INC en Leucemia mieloide aguda · Sindromes mielodisplasicos.
Más ensayos de: Leucemia mieloide aguda · Síndromes mielodisplásicos.
- Fase
- Fase 1/2
- Estado
- Suspendido
- Participantes
- 366
- Centros
- 32
- Fin del objetivo primario
- abr 2026
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en jul 2020.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Dosing completed in all cohorts. Planning underway for potential additional patient cohorts.».
Qué mide
Determine Maximum Tolerated Dose (MTD) of emavusertib (CA-4948) monotherapy (Phase 1) (del registro, en inglés) (28 dias)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a multicenter, open-label, Phase 1/2a dose escalation and expansion study of orally administered emavusertib (CA-4948) monotherapy in adult patients with AML or higher- risk Myelodysplastic Syndrome (hrMDS). Patients enrolling in the Phase 1 dose escalation of the study must meet one of the following criteria prior to consenting to the study: * Relapse/refractory (R/R) AML with FMS-like tyrosine kinase-3 (FLT3) mutations who have been previously treated with a FLT3 inhibitor * R/R AML with spliceosome mutations of splicing factor 3B subunit 1 (SF3B1) or U2AF1 * R/R hrMDS with spliceosome mutations of SF3B1 or U2 small nuclear RNA auxiliary factor 1 (U2AF1) * Number of pretreatments: 1 or 2 The Phase 2a Dose Expansion will be in 3 Cohorts of patients: 1. R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor; 2. R/R AML with spliceosome mutations of SF3B1 or U2AF1; and 3. R/R hrMDS (Revised International Prognostic Scoring System \[IPSS-R\] score \> 3.5) with spliceosome mutations of SF3B1 or U2AF1. All patients above have had ≤ 2 lines of prior systemic anticancer treatment. In previous versions of this protocol there was a Phase 1b portion of the study, in which patients with AML or hrMDS received CA-4948 in combination with venetoclax. This part of the study is no longer open for enrollment.
Más ensayos de CRIS
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Emavusertib | Fase 1/2 | Reclutando pacientes | ago 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Emavusertib | Fase 2 | Reclutando pacientes | nov 2027 (prevista) |
| CI-8993 | Fase 1 | Completado | may 2023 (real) |
| fimepinostat | Fase 1 | Completado | oct 2020 (real) |
| CA-170 | Fase 1 | Completado | may 2020 (real) |
| CUDC-907 | Fase 1 | Completado | may 2019 (real) |
Todos los de CRIS, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04278768), actualizada en mar 2026.