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Acute Myeloid LeukemiaPhase 1NCT07306832

A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

A Phase 1 study testing Pivekimab Sunirine in people with Acute Myeloid Leukemia, run by AbbVie at 14 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith 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 pediatric participants with relapsed or refractory (R/R) AML. Read more about this study

Who is it for?
Ages 6 months to 17 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Pivekimab Sunirine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
14 sitesin 7 countries
Study dates
20 May 2026to Mar 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Must have histologically confirmed acute myeloid leukemia (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).
  • Must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution.
  • Has >= 5% myeloid leukemic blasts in bone marrow at time of relapse or refractory disease and prior to Screening for this study.
  • Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or ECOG score <= 2.
  • May have status of central nervous system (CNS)1, 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 receiving intrathecal therapy and no additional CNS-directed systemic therapy at study entry are eligible and may continue treatment as clinically indicated in accordance with institutional practice.
  • For those participants who have not reached the age of consent, parent or legal guardian with the willingness and ability to provide informed consent and participant willing and able to give assent, as appropriate for age and country.

Who cannot join

  • Known clinically significant cardiac disease.
  • Down syndrome.
  • Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).
  • Symptomatic central nervous system (CNS3) disease
  • Prior history of any severity veno-occlusive disease/sinusoidal obstructive syndrome (VOD/SOS) of the liver.
  • Prior history of hematopoietic stem cell transplant within 6 months prior to Screening without evidence of active GvHD at the time of screening and the participant is off medications to treat or prevent either post-transplant graft-versus-host disease (GvHD) or post-transplant rejection (except for a stable dose of corticosteroids).
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  • Have received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy.
  • Any other known current malignancy requiring therapy.
  • Currently receiving anticancer therapy with antineoplastic intent, including radiotherapy, systemic therapy small molecules, monoclonal antibodies, other investigational agents, or high-dose chemotherapy with the exception of intrathecal therapy.

Trial locations and contacts

14 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

14 sites in 7 countries

United States5 sites, 5 recruiting

  • Children'S Healthcare Of Atlanta - Arthur M. Blank Hospital /ID# 275740

    Atlanta, Georgia, 30329

    Recruiting

  • Children's Medical Center Dallas /ID# 275930

    Dallas, Texas, 75235

    Recruiting

  • Tristar Centennial Medical Center /ID# 275831

    Nashville, Tennessee, 37203

    Recruiting

  • Lucile Packard Children's Hospital /ID# 276015

    Palo Alto, California, 94304

    Recruiting

  • New York Medical College /ID# 275597

    Valhalla, New York, 10595

    Recruiting

Other trials in United States

Australia2 sites, 2 recruiting

  • Perth Children'S Hospital /ID# 275673

    Perth, Western Australia, 6009

    Recruiting

  • The Children's Hospital at Westmead /ID# 275672

    Westmead, New South Wales, 2145

    Recruiting

Other trials in Australia

France2 sites, 2 recruiting

  • Chu Bordeaux - Hopital Pellegrin /ID# 277645

    Bordeaux, New Aquitaine, 33076

    Recruiting

  • Hopital Armand Trousseau /ID# 276231

    Paris, 75571

    Recruiting

Other trials in France

South Korea2 sites, 2 recruiting

  • Seoul National University Hospital /ID# 276978

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

  • Samsung Medical Center /ID# 276979

    Seoul, Seoul Teugbyeolsi, 06351

    Recruiting

Other trials in South Korea

Italy1 site, 1 recruiting

  • Ospedale Pediatrico Bambino Gesu /ID# 275692

    Rome, Roma, 00165

    Recruiting

Other trials in Italy

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital /ID# 276635

    Taipei, 100

    Recruiting

Other trials in Taiwan

United Kingdom1 site, 1 recruiting

  • Cambridge University Hospital /ID# 277041

    Cambridge, Cambridgeshire, CB2 0QQ

    Recruiting

Other trials in United Kingdom

About this study

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

Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith 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 pediatric 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 pediatric participants with a diagnosis of AML will be enrolled in the study at approximately 30 sites around the world.

Read more

Participants will receive intravenous (IV) pivekimab sunirine alone. The total study duration is approximately 28 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Being tested
Pivekimab Sunirine
Keywords
Acute Myeloid Leukemia, Relapsed, Refractory, Pivekimab Sunirine, PVEK, Pediatric
Medical subject headings
Leukemia, Myeloid, Acute, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pivekimab SunirineDrug

    Intravenous

Study groups in NCT07306832
Study groupRoleWhat they receive
Cohort 1: Pivekimab Sunirine Ages 2 to < 6 YearsExperimentalParticipants will receive pivekimab sunirine, as part of the approximately 28 month study duration. If enrolled, subjects aged 6 months to less than 2 years will be included in Cohort 1
Receives: Drug: Pivekimab Sunirine
Cohort 2: Pivekimab Sunirine Ages 6 to < 12 YearsExperimentalParticipants will receive pivekimab sunirine, as part of the approximately 28 month study duration.
Receives: Drug: Pivekimab Sunirine
Cohort 3: Pivekimab Sunirine Ages 12 to < 17 YearsExperimentalParticipants will receive pivekimab sunirine, as part of the approximately 28 month study duration.
Receives: Drug: Pivekimab Sunirine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation

    Number of participants with protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with pivekimab sunirine (PVEK). Severity of TEAEs will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to Approximately 24 Months

  2. Maximum Observed Serum/Plasma Concentration (Cmax) of Intact Antibody-Drug Conjugate (ADC)

    Maximum observed serum/plasma concentration of intact ADC.

    Measured: Up to Approximately 22 Months

  3. Cmax of FGN849 Payload

    Maximum observed serum/plasma concentration of FGN849 payload.

    Measured: Up to Approximately 22 Months

  4. Area Under the Concentration-Time Curve (AUC) of Intact ADC

    Area under the concentration-time curve of intact ADC.

    Measured: Up to Approximately 22 Months

  5. AUC of FGN849 payload

    Area under the concentration-time curve of FGN849 payload.

    Measured: Up to Approximately 22 Months

  6. Time to Cmax (Tmax) of Intact ADC

    Time to Cmax of intact ADC.

    Measured: Up to Approximately 22 Months

  7. Tmax of FGN849 Payload

    Time to Cmax of payload.

    Measured: Up to Approximately 22 Months

Secondary outcomes (6)

  1. Percentage of Participants Achieving Complete Remission (CR)

    CR is defined as Hematologic recovery: Absolute Neutrophil Count (ANC) > 1.0 × 10^9/L (> 1,000/μL) and platelet count > 100 × 10^9/L (> 100,000/μL); < 5% bone marrow blasts; absence of circulating blasts; no evidence of extramedullary disease; no transfusions or support by exogenous growth factors (GCSF) within 7 days prior to response evaluation.

    Measured: Up to Approximately 28 Months

  2. Percentage of Participants Achieving Composite Complete Remission (CR + complete remission with incomplete recovery [CRi])

    Percentage of participants achieving CR + CRi.

    Measured: Up to Approximately 28 Months

  3. Percentage of Participants Achieving Composite Complete Remission (CR + complete remission with partial hematological [CRh])

    Percentage of participants achieving CR + CRh.

    Measured: Up to Approximately 28 Months

  4. Duration of Complete Remission (DOCR)

    DOCR is defined as the first response of CR to the time of relapse or death from any cause, whichever comes first; for participants who did not relapse or die, the duration will be censored at the time of the last response assessment.

    Measured: Up to Approximately 28 Months

  5. Duration of Composite Complete Remission (CR + CRi)

    Duration of composite complete remission (CR + CRi).

    Measured: Up to Approximately 28 Months

  6. Duration of Composite Complete Remission (CR + CRh)

    Duration of composite complete remission (CR + CRh).

    Measured: Up to Approximately 28 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start20 May 2026
  3. Primary completionApr 2028 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07306832
Sponsor's protocol ID
M25-692
Other IDs
2024-520125-36
Status last verified
Oct 2026
First submitted
15 Dec 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pivekimab Sunirine in people with Acute Myeloid Leukemia, run by AbbVie at 14 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Australia, France, South Korea, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation (time frame: Up to Approximately 24 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07306832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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