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 (NEC)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 14 days
Maximum Age: 1 month
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Connecticut
Yale-New Haven Hospital
RECRUITING
New Haven
Florida
BayCare Health System-St. Joseph's Women's Hospital
RECRUITING
Tampa
Illinois
NorthShore University-Evanston Hospital
RECRUITING
Evanston
Oklahoma
Oklahoma Children's Hospital
RECRUITING
Oklahoma City
Pennsylvania
Penn State Health Milton S Hershey Medical Center/Penn State University College of Medicine
RECRUITING
Hershey
University of Pittsburgh Medical Center Magee Womens Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Karin Potoka, MD
kpotoka@noveome.com
412-512-1446
Backup
Shawna M Rose, BS
srose@noveome.com
513-205-1091
Time Frame
Start Date:2024-08-19
Estimated Completion Date:2029-11
Participants
Target number of participants:36
Treatments
Other: Cohort 1 - lower dose active + SOC treatment vs. SOC alone in higher weight range
Infants with weight at diagnosis of NEC ≥1000 g and ≤3000 g; 0.5 mL/kg of ST266, QD, + Standard of Care (SOC) treatment (n=6); SOC (n=3)
Other: Cohort 2 - higher dose active + SOC treatment vs. SOC alone in higher weight range
Infants with weight at diagnosis of NEC ≥1000 g and ≤3000 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)
Other: Cohort 3 - lower dose active + SOC treatment vs. SOC alone in lower weight range
Infants with weight at diagnosis of NEC ≥500 g and ≤999 g; 0.5 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)
Other: Cohort 4 - higher dose active + SOC treatment vs. SOC alone in lower weight range
Infants with weight at diagnosis of NEC ≥500 g and ≤999 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)