USO 24311
Estudio abierto de fase 1/2 de sacituzumab govitecan administrado a una dosis y horario alternativos en participantes con cáncer de mama triple negativo avanzado (GS-US-576-7321).
Tipos de enfermedades: Investigación sobre el cáncer de mama
Requisitos de elegibilidad:
• Women/men with metastatic TNBC - ER/PR <10%; HER2 negative
• Measurable disease per RECIST v1.1
• Prior treatment with a TOP1i or TROP-2-directed ADC excluded
Phase 1:
• PD on ≥1 prior SOC systemic therapy for metastatic disease
• Prior tx with taxane required in (neo)adj or adv setting
• UGT1A1 WT required for safety run-in; any UGT1A1 genotype allowed after
safety run-in
Phase 2:
• No prior systemic therapy for advanced disease (de novo MBC allowed)
• >6 relapse-free interval from curative therapy, if given
• Must have received prior anthracycline in (neo)adj setting or ineligible
• PD-L1 negative - tumor PD-L1 CPS <10 using the PD-L1 IHC 22C3 assay
• Pts with PD-L1 CPS ≥10 eligible if received anti-PD-(L)-1 agent in (neo)adj
setting or if ineligible for anti-PD-(L)1 due to comorbidity
Para más información sobre este juicio , HAGA CLIC AQUÍ.
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