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

Recruiting now · Phase 1/Phase 2

Conditions studied: Necrotizing Enterocolitis

In brief

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.

Key facts

Study ID

NCT06315738

Run by

Noveome Biotherapeutics, formerly Stemnion

People needed

36

Starts

2024-08-19

Expected to finish

2029-11-01

Last updated by the study team

2026-04-13

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born from ≥22 weeks gestational age up to and including 40 weeks gestational age; up to 40 weeks postmenstrual age (gestational age plus chronological age in terms of weeks) with current weight at diagnosis of NEC between ≥500g and ≤3000g, as a result of prematurity and/or IUGR. Parent(s)/legal medical representative(s) voluntarily provides written consent prior to study enrollment.
• Bell's Stage IIA or higher medical NEC (Stages IIA - IIIA only) diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus. The clinician confirms NEC diagnosis by evaluation of the radiologic imaging for confirmed pneumatosis intestinalis. If X-ray is used and is equivocal, an ultrasound (US) may be used, if available, to confirm pneumatosis. If the clinician (Neonatologist and/or Pediatric Surgeon) has differing interpretation from that of the Radiologist, that should be documented in both the medical and research records for accuracy of NEC diagnosis.

You may not qualify if…

• Infants with abdominal perforation.
• 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.

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• Yale-New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• BayCare Health System-St. Joseph's Women's Hospital — Tampa, Florida, United States (enrolling)
• NorthShore University-Evanston Hospital — Evanston, Illinois, United States (enrolling)
• Oklahoma Children's Hospital — Oklahoma City, Oklahoma, United States (enrolling)
• Penn State Health Milton S Hershey Medical Center/Penn State University College of Medicine — Hershey, Pennsylvania, United States (enrolling)
• University of Pittsburgh Medical Center Magee Womens Hospital — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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