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Study identifier: NCT06315738 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Necrotizing Enterocolitis  ·  Sponsor: Noveome Biotherapeutics, formerly Stemnion

PhasePhase 1/Phase 2
Planned participants36
Who can joinAll sexes, 2 Weeks to 8 Weeks
Healthy volunteersNo

About this study

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 description comes directly from the study's public registry record.

Talk to the study team

Karin Potoka, MD  ·  412-512-1446  ·  kpotoka@noveome.com

Shawna M Rose, BS  ·  513-205-1091  ·  srose@noveome.com

Always discuss trial participation with your own doctor first.

Locations (8)

Arkansas Children's HospitalLittle Rock, Arkansas, United StatesRecruiting
University of Arkansas for Medical SciencesLittle Rock, Arkansas, United StatesRecruiting
Yale-New Haven HospitalNew Haven, Connecticut, United StatesRecruiting
BayCare Health System-St. Joseph's Women's HospitalTampa, Florida, United StatesRecruiting
NorthShore University-Evanston HospitalEvanston, Illinois, United StatesRecruiting
Oklahoma Children's HospitalOklahoma City, Oklahoma, United StatesRecruiting
Penn State Health Milton S Hershey Medical Center/Penn State University College of MedicineHershey, Pennsylvania, United StatesRecruiting
University of Pittsburgh Medical Center Magee Womens HospitalPittsburgh, Pennsylvania, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06315738