M25-692 Phase 1B Study with Pivekimab Sunirine in Pediatric Subjects with Acute ML
Research type
Research Study
Full title
A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML)
IRAS ID
1013003
Contact name
Bernhard Dodell
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2024-520125-36
Research summary
Acute myeloid leukemia (AML) is an aggressive blood cancer, with 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 paediatric 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 paediatric 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.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
26/EM/0018
Date of REC Opinion
4 Mar 2026
REC opinion
Further Information Favourable Opinion