Actively Recruiting
Randomized Controlled Phase 1-2 Study of ST266 IV to Assess Safety, Tolerability, and Preliminary Efficacy in Infants With Necrotizing Enterocolitis (NEC)
Led by Noveome Biotherapeutics, formerly Stemnion · Updated on 2026-04-13
36
Participants Needed
8
Research Sites
21 weeks
Total Duration
On this page
Sponsors
N
Noveome Biotherapeutics, formerly Stemnion
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and preliminary effectiveness of ST266 in infants with necrotizing enterocolitis (NEC) at Bell's stage IIA or higher. This Phase 1-2 randomized, controlled, open-label trial focuses on infants with NEC weighing between 500g and 3000g. The study aims to assess adverse events and serious adverse events related to the treatment, alongside early signs of efficacy. The study involves four cohorts based on dose levels (0.5 mL/kg and 1.0 mL/kg) and weight ranges (500-999g and 1000-3000g). Participants are randomly assigned to receive either ST266 plus standard of care (SOC) or SOC alone. Treatment is given once daily intravenously for 10 days, followed by a 28-day follow-up. The Data Safety Monitoring Board reviews safety data before advancing dosing in subsequent cohorts. During the trial, infants will undergo monitoring for adverse events, laboratory tests, and vital signs up to 24 months of age. Researchers will also evaluate clinical measures such as time to resolution of pneumatosis, time to full enteral feeding, need for abdominal surgery, and changes in organ failure scores during treatment. Participation includes regular assessments and monitoring to ensure safety and gather efficacy data over the follow-up period.
CONDITIONS
Brief Title
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born from 63A522 weeks gestational age up to 40 weeks postmenstrual age
- Current weight at NEC diagnosis between 500g and 3000g
- Diagnosed with Bell's Stage IIA or higher medical NEC confirmed by radiologic imaging
- Parent or legal representative provides written consent prior to enrollment
You will not qualify if you...
- Infants with abdominal perforation
- Infants not expected to survive 632 weeks or with lethal conditions requiring hospice or palliative care
- Major congenital anomalies such as cardiac defects or chromosomal disorders
- Mother's receipt of any investigational product during pregnancy
- Infants with malignancies or hypercoagulability disorders
- Infants with known immunodeficiency
- Anatomic defects requiring surgical intervention
- Persistent pulmonary hypertension of newborn
- Congenital or acquired gastrointestinal pathology precluding feeds within 7 days after birth
- Hypoxic ischemic injury
- Polycythemia (greater than 22 g/dL at treatment)
- Positive maternal HIV status
- History of maternal drug abuse (excluding marijuana or prescribed treatment medications)
- Considered unsuitable by Investigator for any reason
- Infants requiring immediate surgical intervention for NEC
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive daily intravenous doses of ST266 for 10 days in addition to standard of care, or standard of care alone, according to their randomized cohort and weight range.
10 treatment cycles (daily visits or dosing events)
Duration - Up to 24 months
Participants are monitored for safety and efficacy outcomes including adverse events and resolution of symptoms up to 24 months of age.
At least 1 follow-up visit at Day 28/1 Month post-treatment and additional assessments as per standard care and study visits
Trial Site Locations
Total: 8 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
BayCare Health System-St. Joseph's Women's Hospital
Tampa, Florida, United States, 33607
Actively Recruiting
5
NorthShore University-Evanston Hospital
Evanston, Illinois, United States, 60201
Actively Recruiting
6
Oklahoma Children's Hospital
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
7
Penn State Health Milton S Hershey Medical Center/Penn State University College of Medicine
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
8
University of Pittsburgh Medical Center Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
Research Team
K
Karin Potoka, MD
S
Shawna M Rose, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here