A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520125-36-00

Enrollment

Registered

2026-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Relapsed or Refractory Acute Myeloid Leukemia; Acute Myeloid Leukemia

Brief summary

Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation, PK parameters for intact ADC and payload (FGN849), including Cmax, AUC, and Tmax

Detailed description

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)

Interventions

DRUGPIVEKIMAB SUNIRINE

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation, PK parameters for intact ADC and payload (FGN849), including Cmax, AUC, and Tmax	—

Secondary

Measure	Time frame
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)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 21, 2026