Calendario›CRIS›Emavusertib
Emavusertib
CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
Ensayo de CURIS INC en Relapsed Hematologic Malignancy · Refractory Hematologic Malignancy · Relapsed Primary Central Nervous System Lymphoma · Refractory Primary Central Nervous System Lymphoma (del registro, en inglés).
- Fase
- Fase 1/2
- Estado
- Reclutando pacientes
- Participantes
- 152
- Centros
- 45
- Fin del objetivo primario
- ago 2026
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2017.
Qué mide
Part A: To determine the safety and tolerability of emavusertib as a monotherapy and in combination with ibrutinib: dose-limiting toxicity (DLT) (del registro, en inglés) (12 meses)
Qué se prueba
Un estudio multicéntrico evalúa la seguridad, farmacocinética y actividad anticancerígena de emavusertib oral, solo o combinado con ibrutinib, en adultos con neoplasias hematológicas en recaída o refractarias.
Lo que dice el documentoThis is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R/R) hematologic malignancies. This trial will be completed in four parts.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R/R) hematologic malignancies. This trial will be completed in four parts. In Part A1, emavusertib will be evaluated first in a dose escalating monotherapy setting to establish the safety and tolerability (complete). In Part A2, emavusertib will be evaluated in combination with ibrutinib at 560 milligrams (mg) once daily (QD) or 420 mg QD as indicated by disease (Part A2 complete). Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in participants with R/R primary central nervous system lymphoma (PCNSL) who have directly progressed on a bruton tyrosine kinase inhibitor (BTKi). In this part of the study, emavusertib will be dosed at 100 mg or 200 mg twice daily (BID) in combination with ibrutinib in 28-day treatment cycles. Part C will comprise 3 treatment arms in the second-line setting to assess the efficacy and safety of emavusertib monotherapy, ibrutinib monotherapy, and emavusertib in combination with ibrutinib in participants with R/R PCNSL who are naïve to BTKi treatment. In this part of the study, eligible second-line participants with R/R PCNSL who are naïve to BTKi treatment will be randomized 1:1:1 to 1 of 3 treatment arms: (1) emavusertib 200 mg BID, (2) ibrutinib 560 mg QD, or (3) emavusertib 200 mg BID in combination with ibrutinib 560 mg QD.
Más ensayos de CRIS
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Emavusertib | Fase 2 | Reclutando pacientes | nov 2027 (prevista) |
| Emavusertib | Fase 1/2 | Suspendido | abr 2026 (prevista, ya pasada: sin actualizar en el registro) |
| 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 (NCT03328078), actualizada en abr 2026.