NCT06315738 Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
| NCT ID | NCT06315738 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Noveome Biotherapeutics, formerly Stemnion |
| Condition | Necrotizing Enterocolitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-08-19 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2024-08-19 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. 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. 2. 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. Exclusion Criteria: 1. Infants with abdominal perforation. 2. 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). 3. Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders/anomalies (e.g., neural tube defect). 4. Mother's receipt of any investigational product during pregnancy. 5. Infants with malignancies (e.g., neoplastic cell growth as a solid tumor or a blood neoplasm, such as congenital leukemia). 6. Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired/inherited disorders (i.e., hemophilia) of coagulation. 7. Infants with a known immunodeficiency (such as galactosemia or agranulocytosis). 8. Infants with anatomic defects that require surgical intervention. 9. Infants with persistent pulmonary hypertension of newborn. 10. Infants with any congenital or acquired gastrointestinal pathology that preclude feeds within 7 days after birth (e.g., duodenal atresia). 11. Infants who have hypoxic ischemic injury (perinatal asphyxia). 12. Infants with polycythemia (at time of treatment) (\>22 g/dL). 13. Positive maternal human immunodeficiency virus status. 14. History of maternal drug abuse (such as amphetamines, opiates, cocaine). This does not include marijuana, or prescription medications for treatment of drug abuse. 15. Considered by the Investigator, for any reason, to be an unsuitable candidate for the study. 16. Infants diagnosed with NEC who will require immediate surgical intervention.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06315738 clinical trial?
This trial is open to participants of all sexes, aged 2 Weeks or older, up to 8 Weeks, studying Necrotizing Enterocolitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06315738 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06315738 currently recruiting?
Yes, NCT06315738 is actively recruiting participants. Contact the research team at kpotoka@noveome.com for enrollment information.
Where is the NCT06315738 trial being conducted?
This trial is being conducted at Little Rock, United States, Little Rock, United States, New Haven, United States, Tampa, United States and 4 additional locations.
Who is sponsoring the NCT06315738 clinical trial?
NCT06315738 is sponsored by Noveome Biotherapeutics, formerly Stemnion. The trial plans to enroll 36 participants.