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

2024-520125-36-00 · tracked via the Priya Life Science EU tracker

Sponsor

AbbVie Deutschland GmbH & Co. KG

Sponsor type

Pharmaceutical company

Therapeutic area

Neoplasms

Decision date

20/04/2026

Enrollment target

Sites

Spain, Hungary, Czechia, France, Italy, Belgium

Condition studied

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

Investigational medicinal product(s)

PIVEKIMAB SUNIRINE

Eligibility

Age group

0-17 years

Sex

Female, Male

Primary endpoint

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

Endpoint detail

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)

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-520125-36-00 on CTIS ↗ ← All trials in the EU