Calendario›NGNE›NL-201
NL-201
NL-201 Monotherapy and in Combination With Pembrolizumab in Patients With Relapsed or Refractory Cancer
Ensayo de Neurogene Inc. en Tumor solido avanzado.
Más ensayos de: Tumor sólido · Tumor sólido avanzado.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 59
- Centros
- 8
- Fin del objetivo primario
- dic 2022
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2021.
Qué mide
Recommended phase 2 dose (RP2D) for NL-201 (Parts 1 and 2) (del registro, en inglés) (hasta el dia 33)
Cómo lo describe el promotor
En el documentoEn inglés, del registroParts 1 and 2 The primary purpose of this study is to understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing. In Part 1, there will be backfill cohorts at certain Data Monitoring Committee (DMC)-cleared dose levels and schedules to collect pharmacokinetic (PK), pharmacodynamic (PD) and response data in certain tumor types or to explore additional pre-medication regimens. Parts 3 and 4 The primary purpose of this study is to understand the safety of NL-201 in combination with pembrolizumab when both drugs are given intravenously in patients with advanced cancer, to evaluate tolerability, and to identify a recommended dose and schedule for further testing.
Más ensayos de NGNE
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| NGN-101 · CLN5-200 | Fase 1/2 | En marcha, sin reclutar | nov 2028 (prevista) |
| NGN-401 | Fase 3 | En marcha, sin reclutar | dic 2029 (prevista) |
| A Natural History Study of Neuronal Ceroid Lipofuscinosis Type 5 (CLN5) | no aplica | Completado | may 2024 (real) |
| CMT4J | no aplica | Interrumpido | feb 2022 (real) |
| AGU | no aplica | Interrumpido | oct 2020 (real) |
Todos los de NGNE, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04659629), actualizada en sep 2024.