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SAR445877
Ensayo de Sanofi en Gastric Cancer · Oesophageal Carcinoma (del registro, en inglés).
Más ensayos de: Cáncer gástrico.
- Fase
- Fase 2
- Estado
- Reclutando pacientes
- Participantes
- 30
- Centros
- 1
- Fin del objetivo primario
- ago 2028
Título oficial en el registro (en inglés): A Dose Optimization/Expansion Study of SAR445877 in Adult Chinese Participants With Advanced Gastric or Gastroesophageal Junction Cancer
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2026.
Qué mide
Objective response rate (From baseline to the end of study, up to approximately 2 years) (del registro, en inglés)
Qué se prueba
Es un estudio de fase 2, abierto, que evalúa SAR445877 en monoterapia en participantes chinos de al menos 18 años con cáncer gástrico avanzado o de la unión gastroesofágica.
Lo que dice el documentoThis is a Phase 2, open-label, dose optimization/expansion study to assess the preliminary efficacy and safety of SAR445877 as a monotherapy for Chinese participants aged at least 18 years with advanced Gastric Cancer(GC)/Gastroesophageal Junction cancer (GEJ). Participants with advanced GC/GEJ who relapsed to at least 1 prior regimen which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care, regardless combined positivity score (CPS) will be randomized in this study.
Traducción automática (claude-haiku-5-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a Phase 2, open-label, dose optimization/expansion study to assess the preliminary efficacy and safety of SAR445877 as a monotherapy for Chinese participants aged at least 18 years with advanced Gastric Cancer(GC)/Gastroesophageal Junction cancer (GEJ). Participants with advanced GC/GEJ who relapsed to at least 1 prior regimen which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care, regardless combined positivity score (CPS) will be randomized in this study. In this study, SAR445877 will be assessed as a monotherapy in approximately 30 participants with advanced unresectable or metastatic GC or Siewert Type 2 and 3 GEJ, and for whom receiving the standard of care (SOC) is not in his or her best interest, or where no SOC is established. Human epidermal growth factor receptor 2 (HER2) positive cases will not be eligible unless they have progressed on a HER2 targeted therapy. Those participants should have received at least 1 prior line of anti-cancer treatment which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care. Metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cases are not eligible.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT07692204), actualizada en jul 2026.