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BNT152
Dose Escalation Trial of BNT152+153 in Patients With Cancer
Ensayo de BioNTech SE en Tumor solido.
Más ensayos de: Tumor sólido.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 86
- Centros
- 7
- Fin del objetivo primario
- sep 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en jun 2021.
Qué mide
Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by causal relationship to trial treatment (del registro, en inglés) (hasta 24 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is an open-label, multisite Phase I dose escalation, safety, pharmacokinetics (PK) and pharmacodynamics (PD) trial of BNT152+153 in various solid tumor indications. The clinical trial will enroll patients with various solid tumors that are metastatic or unresectable for whom there is no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy. The trial consists of Part 1 and Part 2 with adaptive design elements: * Part 1 consists of Groups A and B. * Group A is a BNT153 monotherapy dose escalation in patients with advanced solid malignancies until the maximal tolerated dose (MTD) is defined. If MTD is not reached, maximum administered dose (MAD) may be used for further development (or another dose as determined by the safety review committee \[SRC\]). * Group B is a BNT152 monotherapy dose escalation in patients with advanced solid malignancies until the MTD or optimal biological dose (OBD; the lowest safe dose associated with optimal biological activity) is defined, whichever occurs earlier. * Group A will be activated first while the time point for Group B activation is at sponsor's decision. * Part 2 will start after the MTD or MAD or another dose as determined by the SRC have been established for BNT153 and MTD or OBD for BNT152 in Part 1. Part 2 (Part 2A, 2B and 2C) is a dose escalation of BNT152+153 in patients with advanced solid malignancies until the recommended Phase II dose (RP2D) is defined. * Part 2 may implement a biomarker cohort if a clinical benefit is observed at one or more doses of BNT152+153 that show a clear PD effect in the peripheral blood. The Biomarker Cohort will recruit patients at selected sites.
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 (NCT04710043), actualizada en sep 2025.