RecruitingPhase 1Phase 2NCT06315738

Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis

Randomized, Controlled, Phase 1-2 Open Label Study of ST266 IV Administration to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis

Sponsor

Noveome Biotherapeutics, formerly Stemnion

Enrollment

36 participants

Start Date

Aug 19, 2024

Study Type

INTERVENTIONAL

Conditions

Necrotizing Enterocolitis

Summary

The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC.

Eligibility

Min Age: 2 WeeksMax Age: 8 Weeks

Inclusion Criteria2

Infants born from ≥26 weeks gestational age to 40 weeks gestational age; up to 40 weeks postmenstrual gestational age (gestational age plus chronological age in terms of weeks) with current weight at diagnosis of NEC between ≥800g and ≤3000g as a result of prematurity and/or IUGR. Parent(s)/legal medical representative(s) voluntarily provides written consent prior to study enrollment.
Minimum Bell stage IIA NEC diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus.

Exclusion Criteria16

Infants with abdominal perforation at less than 10 days of life
Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care (e.g., disease has progressed to NEC totalis, or patient has multi-organ system failure).
Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders/anomalies (e.g., neural tube defect).
Mother's receipt of any investigational product during pregnancy.
Infants with malignancies (e.g., neoplastic cell growth as a solid tumor or a blood neoplasm, such as congenital leukemia).
Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired/inherited disorders (i.e., hemophilia) of coagulation.
Infants with a known immunodeficiency (such as galactosemia or agranulocytosis).
Infants with anatomic defects that require surgical intervention.
Infants with persistent pulmonary hypertension of newborn.
Infants with any congenital or acquired gastrointestinal pathology that preclude feeds within 7 days after birth (e.g., duodenal atresia).
Infants who have hypoxic ischemic injury (perinatal asphyxia).
Infants with polycythemia (at time of treatment) (\>22 g/dL).
Positive maternal human immunodeficiency virus status.
History of maternal drug abuse (such as amphetamines, opiates, cocaine). This does not include marijuana, or prescription medications for treatment of drug abuse.
Considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Infants diagnosed with NEC who will require immediate surgical intervention.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALST266

Patients randomized to investigative drug product (ST266) will receive either 0.5 mL/kg or 1.0 mL/kg of ST266 QD in addition to Standard of Care treatment; Patients randomized to SOC will receive standard of care treatment only.