Набира участници
Фаза 1
2024-520125-36-00
A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Relapsed or Refractory Acute Myeloid Leukemia; Acute Myeloid Leukemia
Acute Myeloid Leukemia
AbbVie Deutschland GmbH & Co. KG
Налично на:
Trial status: Authorised
Complete Remission (CR), Composite Complete Remission (CR + CRi), Composite Complete Remission (CR + CRh), Duration of Complete Remission (DOCR), Duration of Composite Complete Remission (CR + CRi), Duration of Composite Complete Remission (CR + CRh)
Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation, PK parameters for intact ADC and payload (FGN849), including Cmax, AUC, and Tmax
Complete Remission (CR), Composite Complete Remission (CR + CRi), Composite Complete Remission (CR + CRh), Duration of Complete Remission (DOCR), Duration of Composite Complete Remission (CR + CRi), Duration of Composite Complete Remission (CR + CRh)
Age group: 0-17 years
Gender: Female, Male
Target enrollment: 12 participants
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