A Phase 1/2 interventional study of ST266 in Necrotizing Enterocolitis, sponsored by Noveome Biotherapeutics, formerly Stemnion. Recruiting at 8 sites in United States. Open to participants aged 2 Weeks to 8 Weeks. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Noveome Biotherapeutics, formerly Stemnion · Phase 1/2, Interventional, and Treatment
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.
This Phase 1-2 clinical trial is a randomized, controlled, open-label study using a modified sequential cohort design. Assignment to cohorts will be based on the following dosages and weight ranges: 0.5 mL/kg and 1.0 mL/kg; weight ≥1000 g and ≤3000 g, and weight ≥500 g and ≤999 g.
In each cohort, patients will be randomized to either ST266 + SOC or SOC alone. In the first cohort, the first three patients randomized to ST266 were staggered, where each patient completed their 10-day treatment period containing 10 treatment cycles and Day 28/1 Month follow-up visit and were evaluated by the Data Safety Monitoring Board (DSMB), before dosing of the next patient occurred. Patients randomized to SOC alone followed the treatment plan as dictated by the Investigator site SOC procedures and were evaluated for the same inclusion/exclusion criteria and selected endpoints for analysis. If for any reason a patient was withdrawn, the decision for replacement was determined by the DSMB.
Dosing for the next cohort will occur after review of safety data up to and including Day 28/1 Month post-treatment follow-up visit from all patients in Cohort 1. DSMB reviews will include comprehensive safety data analysis of data available at that time. In Cohorts 2, 3, and 4, only a single sentinel ST266-treated patient will be required to complete their 10-day treatment period containing 10 treatment cycles and Day 28/1 Month follow-up visit and be evaluated by the Data Safety Monitoring Board (DSMB), before dosing of the next patient occurs. Given that Cohort 2 shares the same weight range and Cohort 3 the same dose as Cohort 1, Cohorts 2 and 3 may be opened for enrollment in parallel. If any safety event occurs in either Cohort 2 or 3, the DSMB will promptly evaluate and determine whether to continue the study and/or reinstate patient staggering.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 36 is below the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Noveome Biotherapeutics, formerly Stemnion is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Biological: ST266
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)
Biological: ST266
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)
Biological: ST266
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)
Biological: ST266
Patients randomized to investigative drug product (ST266) will receive either 0.5 mL/kg or 1.0 mL/kg of ST266 QD in addition to Standard of Care treatment; Patients randomized to SOC will receive standard of care treatment only.
Safety and Tolerability endpoint: incidence of adverse events
Patients will be assessed for safety and tolerability of ST266 treatment given IV (two dose options: 0.5mL/kg or 1.0mL/kg) via review of treatment emergent adverse events (TEAEs). AEs are defined as per the International Neonatal Consortium (INC) neonatal AE severity scale (NAESS): Mild, Moderate, Severe, Life Threatening, Death. Relatedness to study drug (ST266) will also be assessed.
Time frame: From date of randomization through 24 months of age
Safety and Tolerability endpoint: incidence of serious adverse events
Patients will be assessed for safety and tolerability of ST266 treatment given IV (two dose options: 0.5mL/kg or 1.0mL/kg) via review of serious adverse events, defined as: any event that results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or may jeopardize patient so that requires intervention to prevent prior noted outcomes (includes study drug related dose-limiting toxicities and infusion reactions)
Time frame: From date of randomization through 24 months of age
Safety and Tolerability endpoint: Changes in labs and vitals relative to disease progression
Patients will be assessed for safety and tolerability of ST266 treatment given IV (two dose options: 0.5mL/kg or 1.0mL/kg) by evaluating clinically significant changes in labs and vitals as to relatedness to disease progression and study drug effects, including assessment of vital signs (temperature, systolic and Mean arterial blood pressure (mmHg), respiratory rate, heart rate, and percent oxygen saturation as measured by pulse oximetry as noted in The Harriet Lane Handbook, 21st ed., 2018), and hematology and chemistry lab tests, which will be measured against standard laboratory acceptable ranges for premature infants.
Time frame: From date of randomization through 24 months of age
Efficacy endpoint: Time to pneumatosis resolution
Pneumatosis is considered resolved when no longer observed on abdominal x-ray
Time frame: From date of NEC diagnosis until resolved, up to 10 days
Efficacy endpoint: Time to full enteral nutrition assessment
Defined as no longer receiving total parenteral nutrition (TPN)
Time frame: From date of completion of antibiotics and/or IP treatment until full feeding tolerance reached, 3-5 days
Efficacy endpoint: Incidence of abdominal surgical intervention
Abdominal surgical intervention defined as laparotomy, including drain placement
Time frame: Assessed from Day 1/Baseline visit through 24 months of age
Efficacy endpoint: Change in Neonatal Sequential Organ Failure Assessment (nSOFA) score
nSOFA score is a neonatal sequential organ failure assessment of three organ systems: respiratory score criteria (range: 0-8); cardiovascular score criteria (range: 0-4); and Hematologic score criteria (range: 0-3) with a total score range: 0 (best) to 15 (worst)
Time frame: From Randomization/Day 1 through Day 10 of treatment period (10 days).
Exploratory endpoint: All cause mortality
Assessment of all deaths that occurred during the study
Time frame: From Day1/Baseline through 24 months of age
Exploratory endpoint: Length of stay in the NICU
Defined as total number of days from Day1/Baseline until date released from NICU
Time frame: From Day1/Baseline until date released from NICU - through 24 months of age
Exploratory endpoint: Change in weight over time
Weight will be measured in grams (g)
Time frame: From Day1/Baseline through 24 months of age
Exploratory endpoint: Change in length over time
Length will be measured in centimeters (cm)
Time frame: From Day1/Baseline through 24 months of age
Exploratory endpoint: Change in head circumference over time
Circumference will be measured in centimeters (cm) and will be used to ensure normal head growth.
Time frame: From Day1/Baseline through 24 months of age
Exploratory endpoint: Number of significant apnea events/day over time
Significant apnea: any apnea for greater than 20 seconds
Time frame: From Day1/Baseline through 1 month follow-up visit - up to 2 months
Exploratory endpoint: Number of significant bradycardia events/day over time
Significant bradycardia: any bradycardia heart rate \< 70BPM for \> 6 seconds
Time frame: From Day1/Baseline through 1 month follow-up visit - up to 2 months
Exploratory endpoint: Number of significant temperature instability events/day over time
Significant temperature instability event: temperature \< 36.5C or \> 37.5C outside neutral/thermal environment or requires a change in isolette temperature outside of standard protocol
Time frame: From Day1/Baseline through 1 month follow-up visit - up to 2 months
Exploratory endpoint: Time to return to normal bowel sounds
Defined as are typically soft and gurgling, indicating pneumatosis resolution and no feeding intolerance, no bowel obstruction or perforation.
Time frame: From date of NEC diagnosis until resolved, up to 10 days
Exploratory endpoint: Change in serum C-reactive protein (CRP)
Included as part of labs being assessed per standard of care treatment
Time frame: To be assessed on Day2 and Day8 during treatment period; and 2 weeks and 1 month post treatment
Exploratory endpoint: Time to return to normal serum platelet count levels
Included as part of labs being assessed per standard of care treatment
Time frame: To be assessed on Day2 and Day8 during treatment period; and 2 weeks and 1 month post treatment
Exploratory endpoint: Incidence of intestinal or colonic strictures
Measured by fluoroscopic study (barium enema or upper gastrointestinal scope); only conducted if infant had symptoms indicating partial bowel obstruction (e.g., feeding intolerance, abdominal distension, bilious emesis).
Time frame: From Day1/Baseline through Day28/1 month post treatment follow up visit
Exploratory endpoint: Incidence of sepsis
Defined as presence of a pathogenic bacteria in blood culture or two positive blood cultures
Time frame: From Day1/Baseline through Day 28/1 month post treatment follow up visit
Exploratory endpoint: Incidence of retinopathy
To be monitored while in NICU
Time frame: From Day1/Baseline until resolved - through 24 months of age
Exploratory endpoint: Incidence of bronchopulmonary dysplasia (BPD)
To be identified at 36 weeks CGA and at discharge from NICU
Time frame: At 36 weeks of age and at discharge from NICU - up to 6 months
Exploratory endpoint: Incidence of pulmonary hypertension (PH)
To be identified at 36 weeks CGA and at discharge from NICU
Time frame: At 36 weeks of age and at discharge from NICU - up to 6 months
Exploratory endpoint: Incidence of periventricular leukomalacia
To be measured via any form of imaging and noted if any symptoms observed
Time frame: From Day 1 post treatment follow up visit through 24 months of age
Plan to share: No
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Studies of the drug tested here: ST266
Noveome Biotherapeutics, formerly Stemnion