Clinical trial • Phase I • Oncology
PIVEKIMAB SUNIRINE for Acute myeloid leukemia | Relapsed or refractory acute myeloid leukemia
Phase I trial of PIVEKIMAB SUNIRINE for Acute myeloid leukemia | Relapsed or refractory acute myeloid leukemia. 80 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Acute myeloid leukemia | Relapsed or refractory acute myeloid leukemia
- Trial Stage
- Phase I
- Drug Modality
- ADC
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 12-12-2025
- First CTIS Authorization Date
- 20-04-2026
Trial design
Phase I trial across 9 sites in Belgium, Czechia, France and others.
- Biomarker Stratified
- True, biomarker: CD123; strata: CD123-positive
- Target Sample Size
- 80
Eligibility
Recruits 80 paediatric patients.
Inclusion criteria
- {"criterion_text":"-Participants must have histologically confirmed AML meeting one of the following disease criteria:• Second or greater relapse OR • Disease refractory to second or subsequent line of therapy (defined as resistant disease after at least one cycle of each treatment regimen)"}
- {"criterion_text":"-Participants must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution."}
- {"criterion_text":"-Participant has ≥5% myeloid leukemic blasts in bone marrow at time of relapse or refractory disease and prior to Screening for this study."}
- {"criterion_text":"-Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (≥ 16 years old at evaluation) score ≥ 50 or ECOG score ≤ 2."}
- {"criterion_text":"-Participants may have status of CNS1, CNS2, or CNS3 disease without clinical signs or neurologic symptoms suggestive of CNS leukemia, such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome. Participants may have non-CNS extramedullary disease."}
Exclusion criteria
- {"criterion_text":"-Participant has known clinically significant cardiac disease."}
- {"criterion_text":"-Participant with Down syndrome"}
- {"criterion_text":"-Participant has acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML)"}
- {"criterion_text":"-Participant has symptomatic central nervous system (CNS3) disease"}
- {"criterion_text":"-Participant has prior history of any severity VOD/SOS (veno-occlusive disease/sinusoidal obstructive syndrome) of the liver."}
- {"criterion_text":"-Participants who have received prior CAR-T therapy"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation","definition_or_measurement_approach":""}
- {"endpoint_text":"-PK parameters for intact ADC and payload (FGN849), including Cmax, AUC, and Tmax","definition_or_measurement_approach":"Pharmacokinetic parameters for intact ADC and payload (FGN849) measured as Cmax, AUC, and Tmax."}
Secondary endpoints
- {"endpoint_text":"-Complete Remission (CR)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Composite Complete Remission (CR + CRi)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Composite Complete Remission (CR + CRh)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Duration of Complete Remission (DOCR)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Duration of Composite Complete Remission (CR + CRi)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Duration of Composite Complete Remission (CR + CRh)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 46
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 18
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-03-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 31
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Pediatric Hemato-Oncology & Stem Cell Transplantation
- Principal Investigator Name
- Barbara De Moerloose
- Principal Investigator Email
- barbara.demoerloose@uzgent.be
- Contact Person Name
- Barbara De Moerloose
- Contact Person Email
- barbara.demoerloose@uzgent.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 20-03-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 33
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Department of Pediatric Hematology and Oncology
- Principal Investigator Name
- Lucie Sramkova
- Principal Investigator Email
- lucie.sramkova@fnmotol.cz
- Contact Person Name
- Lucie Sramkova
- Contact Person Email
- lucie.sramkova@fnmotol.cz
France
- Earliest CTIS Part Ii Submission Date
- 31-03-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 22
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Trousseau Hospital
- Department Name
- Pediatric hematology and oncology
- Principal Investigator Name
- Arnaud Petit
- Principal Investigator Email
- arnaud.petit@aphp.fr
- Contact Person Name
- Arnaud Petit
- Contact Person Email
- arnaud.petit@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Pediatric hematology and oncology
- Principal Investigator Name
- Stephane Ducassou
- Principal Investigator Email
- stephane.ducassou@chu-bordeaux.fr
- Contact Person Name
- Stephane Ducassou
- Contact Person Email
- stephane.ducassou@chu-bordeaux.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 25-03-2026
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 30
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- Clinical Oncohaematology and Cell Therapy Studies
- Principal Investigator Name
- Franco Locatelli
- Principal Investigator Email
- franco.locatelli@opbg.net
- Contact Person Name
- Franco Locatelli
- Contact Person Email
- franco.locatelli@opbg.net
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Pediatric Hematology-Oncology Unit
- Principal Investigator Name
- RICCARDO MASETTI
- Principal Investigator Email
- riccardo.masetti5@unibo.it
- Contact Person Name
- RICCARDO MASETTI
- Contact Person Email
- riccardo.masetti5@unibo.it
Spain
- Earliest CTIS Part Ii Submission Date
- 23-03-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 30
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- Hematologist Service
- Principal Investigator Name
- Albert CATALA TEMPRANO
- Principal Investigator Email
- albert.catala@sjd.es
- Contact Person Name
- Albert CATALA TEMPRANO
- Contact Person Email
- albert.catala@sjd.es
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Paediatric Haemato-Oncology Service
- Principal Investigator Name
- Alba Rubio
- Principal Investigator Email
- alba.rubio@salud.madrid.org
- Contact Person Name
- Alba Rubio
- Contact Person Email
- alba.rubio@salud.madrid.org
Hungary
- Earliest CTIS Part Ii Submission Date
- 27-03-2026
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Semmelweis University
- Department Name
- Gyermekgyogyaszati Klinika Tuzolto Utcai Reszleg
- Principal Investigator Name
- Andrea Ponyi
- Principal Investigator Email
- ponyi.andrea@gyerekklinika.com
- Contact Person Name
- Andrea Ponyi
- Contact Person Email
- ponyi.andrea@gyerekklinika.com
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Third parties
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Hematologics Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"Central IRB for US sites (sponsorDuties code: 15)","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- PIVEKIMAB SUNIRINE
- Active Substance
- PIVEKIMAB SUNIRINE
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS USE
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)