Calendario›INO›INO-5401
INO-5401
INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
Ensayo de INOVIO PHARMACEUTICALS, INC. en Carcinoma urotelial.
Más ensayos de: Carcinoma urotelial.
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 35
- Centros
- 11
- Fin del objetivo primario
- may 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en jul 2018.
Qué mide
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) Treatment (del registro, en inglés) (hasta unos 71 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis was a Phase I/IIA, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with atezolizumab in participants with locally advanced unresectable or metastatic/recurrent Urothelial Carcinoma (UCa). The trial population was divided into two cohorts: Cohort A: participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-programmed death receptor-1/programmed death receptor ligand-1 (anti-PD-1/PD-L1) therapy; Cohort B: participants with locally advanced unresectable or metastatic/recurrent UCa, who were treatment naïve and ineligible for cisplatin-based chemotherapy. A safety run-in was performed using a modified rolling six design, enrolling up to 6 participants (safety analysis participants) from Cohort A.
Más ensayos de INO
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| INO-5401 | Fase 1/2 | En marcha, sin reclutar | dic 2026 (prevista) |
| INO-4800 | Fase 1 | Retirado antes de empezar | mar 2024 (prevista, ya pasada: sin actualizar en el registro) |
| INO-4700 | Fase 2 | Completado | ene 2023 (real) |
| INO-3107 | Fase 1/2 | Completado | dic 2022 (real) |
| INO-4500 | Fase 1 | Completado | oct 2022 (real) |
| INO-4800 | Fase 2/3 | Interrumpido | sep 2022 (real) |
Todos los de INO, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03502785), actualizada en sep 2026.