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)

NCT07306832 | Not Yet Recruiting Phase 1

• 2 other identifiers: M25-6922024-520125-36
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Relapsed; Refractory; Pivekimab Sunirine; PVEK; Pediatric

Outcome Measures

Primary Outcomes (7)

• 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.

  Up to Approximately 24 Months

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

  Maximum observed serum/plasma concentration of intact ADC.

  Up to Approximately 22 Months

• Cmax of FGN849 Payload

  Maximum observed serum/plasma concentration of FGN849 payload.

  Up to Approximately 22 Months

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

  Area under the concentration-time curve of intact ADC.

  Up to Approximately 22 Months

• AUC of FGN849 payload

  Area under the concentration-time curve of FGN849 payload.

  Up to Approximately 22 Months

• Time to Cmax (Tmax) of Intact ADC

  Time to Cmax of intact ADC.

  Up to Approximately 22 Months

• Tmax of FGN849 Payload

  Time to Cmax of payload.

  Up to Approximately 22 Months

Secondary Outcomes (6)

• Percentage of Participants Achieving Complete Remission (CR)

  Up to Approximately 28 Months

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

  Up to Approximately 28 Months

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

  Up to Approximately 28 Months

• Duration of Complete Remission (DOCR)

  Up to Approximately 28 Months

• Duration of Composite Complete Remission (CR + CRi)

  Up to Approximately 28 Months

Study Arms (3)

Cohort 1: Pivekimab Sunirine Ages 2 to < 6 Years

EXPERIMENTAL

Participants 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

Drug: Pivekimab Sunirine

Cohort 2: Pivekimab Sunirine Ages 6 to < 12 Years

EXPERIMENTAL

Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration.

Drug: Pivekimab Sunirine

Cohort 3: Pivekimab Sunirine Ages 12 to < 17 Years

EXPERIMENTAL

Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration.

Drug: Pivekimab Sunirine

Interventions

Pivekimab Sunirine DRUG

Intravenous

Cohort 1: Pivekimab Sunirine Ages 2 to < 6 Years; Cohort 2: Pivekimab Sunirine Ages 6 to < 12 Years; Cohort 3: Pivekimab Sunirine Ages 12 to < 17 Years

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may have non-CNS extramedullary disease.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share