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BNT323 · Fern-EC-01

A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer

Ensayo de BioNTech SE en Cancer de endometrio.

Más ensayos de: Cáncer de endometrio.

Fase

Fase 3

Estado

Reclutando pacientes

Participantes

480

previstos

Centros

191

Fin del objetivo primario

mar 2028

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2025.

Qué mide

Cohorte 1: SLP evaluada por revision central independiente ciega (BICR) en participantes con cancer de endometrio recurrente HER2 IHC 1+/2+ (hasta unos 53 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample. In Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel \[or docetaxel, if participants cannot take paclitaxel\]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs). In Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment. The safety of BNT323 will also be assessed by following the occurrence of unfavorable/adverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life.

Más ensayos de BNTX

Todos los de BNTX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06340568), actualizada en sep 2026.