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A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

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NCT07306832 · readout ≤ 620 d

Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.

Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
18estimated
Sites
11
Countries
Australia, France, Italy +3

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2026-05-20actualWhen the study began enrolling
Primary completionApr 2028estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionMar 2030estimatedThe whole study's end, after follow-up
First posted2025-12-29actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-14actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Acute Myeloid Leukemia

Intervention

  • Drug: Pivekimab Sunirine

Primary outcomes

what the primary-completion date above is the date OF
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation
measured Up to Approximately 24 Months
Maximum Observed Serum/Plasma Concentration (Cmax) of Intact Antibody-Drug Conjugate (ADC)
measured Up to Approximately 22 Months
Cmax of FGN849 Payload
measured Up to Approximately 22 Months
Area Under the Concentration-Time Curve (AUC) of Intact ADC
measured Up to Approximately 22 Months
AUC of FGN849 payload
measured Up to Approximately 22 Months
Time to Cmax (Tmax) of Intact ADC
measured Up to Approximately 22 Months
Tmax of FGN849 Payload
measured Up to Approximately 22 Months

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