RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-19
Study Completion:2029-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06315738

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Weeks to 8 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Premature (≥26 and ≤36 weeks gestational age) infant weight between ≥800g and ≤3000g. Parent(s)/legal medical representative(s) voluntarily provides written consent prior to study enrollment.
  2. 2. Minimum Bell stage IIA NEC diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus.
  1. 1. Infants with abdominal perforation at less than 10 days of life
  2. 2. Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care.
  3. 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. 4. Mother's receipt of any investigational product during pregnancy.
  5. 5. Infants with malignancies.
  6. 6. Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired/inherited disorders (i.e., hemophilia) of coagulation.
  7. 7. Infants with a known immunodeficiency (such as galactosemia or agranulocytosis).
  8. 8. Infants with anatomic defects that require surgical intervention.
  9. 9. Infants with persistent pulmonary hypertension of newborn.
  10. 10. Infants with any congenital or acquired gastrointestinal pathology that preclude feeds within 7 days after birth (e.g., duodenal atresia).
  11. 11. Infants who have hypoxic ischemic injury (perinatal asphyxia).
  12. 12. Infants with polycythemia (at time of treatment) (\>22 g/dL).
  13. 13. Positive maternal human immunodeficiency virus status.
  14. 14. History of maternal drug abuse.
  15. 15. Considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

Contacts and Locations

Study Contact

Karin Potoka, MD
CONTACT
412-512-1446
kpotoka@noveome.com
Shawna M Rose, BS
CONTACT
513-205-1091
srose@noveome.com

Study Locations (Sites)

Orlando Health, Inc. Winnie Palmer Hospital for Women and Babies
Orlando, Florida, 32806
United States
BayCare Health System-St. Joseph's Women's Hospital
Tampa, Florida, 33607
United States
NorthShore University-Evanston Hospital
Evanston, Illinois, 60201
United States
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710
United States
Oklahoma Children's Hospital
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: Noveome Biotherapeutics, formerly Stemnion

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-19
Study Completion Date2029-11

Study Record Updates

Study Start Date2024-08-19
Study Completion Date2029-11

Terms related to this study

Keywords Provided by Researchers

  • Necrotizing Enterocolitis
  • NEC

Additional Relevant MeSH Terms

  • Necrotizing Enterocolitis