Recruiting Phase 1 2024-520125-36-00

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

Phase 1 – testing safety in a small group of people

Conditions: Relapsed or Refractory Acute Myeloid Leukemia; Acute Myeloid Leukemia Acute Myeloid Leukemia

Sponsor: AbbVie Deutschland GmbH & Co. KG

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Overview

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

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)

Who can participate

Age group: 0-17 years Gender: Female, Male Target enrollment: 12 participants

Interventions

PIVEKIMAB SUNIRINE

Drug

Locations 4

Belgium (1)

Czech Republic (1)

France (1)

Spain (1)

Status

Recruiting

Phase

Phase 1

Study type

INTERVENTIONAL

Sex

Male and female

Healthy volunteers

Start date

20.04.2026

Registry ID

2024-520125-36-00

Source

euclinicaltrials.eu

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