Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment. This study will assess the adverse events and how pivekimab sunirine moves through the body in pediatric participants with relapsed or refractory (R/R) AML. Pivekimab sunirine is a drug being evaluated in the treatment of AML. This is an open label, single arm study, participants will be enrolled in 1 of the 3 cohorts based on their age and will receive pivekimab sunirine at a dose based on their weight. Around 18 pediatric participants with a diagnosis of AML will be enrolled in the study at approximately 30 sites around the world. Participants will receive intravenous (IV) pivekimab sunirine alone. The total study duration is approximately 28 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation
Timeframe: Up to Approximately 24 Months
Maximum Observed Serum/Plasma Concentration (Cmax) of Intact Antibody-Drug Conjugate (ADC)
Timeframe: Up to Approximately 22 Months
Cmax of FGN849 Payload
Timeframe: Up to Approximately 22 Months
Area Under the Concentration-Time Curve (AUC) of Intact ADC
Timeframe: Up to Approximately 22 Months
AUC of FGN849 payload
Timeframe: Up to Approximately 22 Months
Time to Cmax (Tmax) of Intact ADC
Timeframe: Up to Approximately 22 Months
Tmax of FGN849 Payload
Timeframe: Up to Approximately 22 Months