A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)
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.
Arms & interventions
- DrugPivekimab Sunirine
Intravenous
Outcome measures
Primary
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.
Time frame: 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.
Time frame: Up to Approximately 22 Months
Cmax of FGN849 Payload
Maximum observed serum/plasma concentration of FGN849 payload.
Time frame: Up to Approximately 22 Months
Area Under the Concentration-Time Curve (AUC) of Intact ADC
Area under the concentration-time curve of intact ADC.
Time frame: Up to Approximately 22 Months
AUC of FGN849 payload
Area under the concentration-time curve of FGN849 payload.
Time frame: Up to Approximately 22 Months
Time to Cmax (Tmax) of Intact ADC
Time to Cmax of intact ADC.
Time frame: Up to Approximately 22 Months
Tmax of FGN849 Payload
Time to Cmax of payload.
Time frame: Up to Approximately 22 Months
Secondary
Percentage of Participants Achieving Complete Remission (CR)
Time frame: Up to Approximately 28 Months
Percentage of Participants Achieving Composite Complete Remission (CR + complete remission with incomplete recovery [CRi])
Time frame: Up to Approximately 28 Months
Percentage of Participants Achieving Composite Complete Remission (CR + complete remission with partial hematological [CRh])
Time frame: Up to Approximately 28 Months
Duration of Complete Remission (DOCR)
Time frame: Up to Approximately 28 Months
Duration of Composite Complete Remission (CR + CRi)
Time frame: Up to Approximately 28 Months
Duration of Composite Complete Remission (CR + CRh)
Time frame: Up to Approximately 28 Months
Eligibility criteria
Study locations (3)
Lucile Packard Children's Hospital /ID# 276015
Palo Alto, California, 94304
New York Medical College /ID# 275597
Valhalla, New York, 10595
Tristar Centennial Medical Center /ID# 275831
Nashville, Tennessee, 37203