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)
← catalyst calendarNCT07306832 · 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| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-05-20 | actual | When the study began enrolling |
| Primary completion | Apr 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | actual | The 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 OFNumber 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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