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SLS009
Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
Ensayo de SELLAS Life Sciences Group, Inc. en Neoplasias hematologicas.
Más ensayos de: Neoplasias hematológicas.
- Fase
- Fase 1/2
- Estado
- Reclutando pacientes
- Participantes
- 160
- Centros
- 32
- Fin del objetivo primario
- dic 2026
previstos
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en may 2021.
Qué mide
Safety and Tolerability: Dose Limiting Toxicities (DLTs) (21 to 28 days) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroSLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with relapsed/refractory AML, Group 2 in patients with relapse/refractory lymphoma/CLL/SLL). The safety, tolerability, and antitumor activity of SLS009 in combination with venetoclax and azacitidine in patient with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens are being assessed in five cohorts of the expansion Group 3. Groups 4 and 5 have been added to evaluate efficacy, safety, and tolerability of GFH009 in combination with venetoclax and azacitidine in newly diagnosed AML patients who are less likely to benefit from standard induction treatment with venetoclax plus HMA only regimens.
Más ensayos de SLS
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Galinpepimut-S · REGAL | Fase 3 | En marcha, sin reclutar | dic 2025 (prevista, ya pasada: sin actualizar en el registro) |
| Galinpepimut-S | no aplica | Disponible por acceso ampliado | sin fecha |
| galinpepimut-S | Fase 1/2 | Completado | jul 2022 (real) |
| Galinpepimut-S | Fase 1/2 | Completado | dic 2016 (real) |
| Galinpepimut-S + Montanide +… | Fase 2 | Completado | nov 2016 (real) |
| Galinpepimut-S | Fase 2 | Completado | sep 2016 (real) |
Todos los de SLS, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04588922), actualizada en sep 2026.