Calendario›BNTX›BNT321 0.5 mg
BNT321 0.5 mg
Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma
Ensayo de BioNTech SE en Cancer de pancreas.
Más ensayos de: Cáncer de páncreas.
- Fase
- Fase 1/2
- Estado
- Interrumpido
- Participantes
- 1
- Centros
- 2
- Fin del objetivo primario
- sep 2024
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en mar 2024.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor decision».
Qué mide
Phase 1 - The Number and Percentage of Participants With at Least One Dose of Investigational Medicinal Product (IMP) Reporting Treatment Emergent Adverse Events (TEAEs) (from the start of study drug treatment until the end of study (i.e., 164 days)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study was designed as a Phase 1/randomized Phase 2 open-label study of modified(m) FOLFIRINOX ± BNT321 for adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) patients post R0 or R1 resection. The Phase 1, dose escalation part of this study was planned to be a limited evaluation of two planned BNT321 dose levels (DLs) in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks). Following completion of the dose escalation Phase 1 and identification of the recommended Phase 2 dose (RP2D), the study was designed as a 2-arm, randomized Phase 2 of mFOLFIRINOX ± BNT321 to evaluate the efficacy of mFOLFIRINOX + BNT321 versus mFOLFIRINOX alone as adjuvant therapy in PDAC patients post R0 or R1 resection. Treatment cycles were every 2 weeks (14 days).
Más ensayos de BNTX
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| BNT164a1 | Fase 1/2 | En marcha, sin reclutar | mar 2026 (real) |
| BNT162b2 Vaccine | Fase 3 | En marcha, sin reclutar | jul 2026 (prevista, ya pasada: sin actualizar en el registro) |
| BNT314 | Fase 1 | En marcha, sin reclutar | ago 2026 (real) |
| BNT163 | Fase 1 | En marcha, sin reclutar | oct 2026 (prevista) |
| RO7198457 intravenous | Fase 2 | En marcha, sin reclutar | nov 2026 (prevista) |
| BNT351 | Fase 1 | Reclutando pacientes | nov 2026 (prevista) |
Todos los de BNTX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06069778), actualizada en oct 2025.