USO 23287
Ensayo clínico de fase III, aleatorizado, multicéntrico y abierto, en el que se compara el BNT323/DB-1303 con la quimioterapia elegida por los investigadores en pacientes previamente tratadas con cáncer de endometrio recurrente que expresan HER2 (BNT323-01)
Tipos de enfermedades: Investigación sobre el cáncer ginecológico
Requisitos de elegibilidad:
• Histologically confirmed endometrial cancer (EC)
• Uterine carcinosarcoma is allowed, but true sarcomas excluded
• HER2 IHC 1+/2+ (Cohort 1) or 3+ (Cohort 2) by central testing
• Measurable disease per RECIST 1.1
• Have recurrent EC and:
• Recurrence <12 months after plt-based chemo as adj tx for Stage I-III OR
• Recurrence after plt-based chemo in recurrent/metastatic setting
• Have received prior ICI tx (anti-PD-(L)1)
• Up to 3 lines of prior tx.
• Prior hormonal or radiation tx do not count as prior lines of tx
• Neoadjuvant followed by adjuvant tx is considered 1 line of tx
• Discontinuation due to toxicity followed by start of new anti-cancer tx
counts as 1 line of tx
• Prior tx with TOP1i, including ADCs, are excluded
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