Actively Recruiting
Phase 1 Study of SER-155, a Live Bacterial Therapy, for First Treatment of Immunotherapy-Related Enterocolitis and Diarrhea
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-07-28
15
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of SER-155, an experimental live bacterial therapeutic, as a first treatment for people experiencing diarrhea related to immunotherapy-induced enterocolitis irEC. This study focuses on adults with grade 2-3 diarrhea due to irEC who have not received immunosuppressive therapy before. The trial aims to find out if SER-155 causes few or mild side effects while addressing these symptoms. Participants will receive SER-155 orally, which consists of 16 unique human-commensal bacterial strains encapsulated for ingestion. The study is single-arm and open-label, meaning all participants will receive this experimental treatment without a comparison group. The treatment and observation will last up to one year, with assessments at various time points including days 15 and 43. During the study, participants will be monitored for treatment-related side effects and clinical responses to irEC without immunosuppressive drugs. Researchers will collect data on adverse events, treatment response and remission rates, and bacterial strain detection in the participants. The study involves regular assessments over a year to carefully track safety and treatment outcomes.
CONDITIONS
Brief Title
A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
Research Team
D
David Faleck, MD
M
Michael Postow, MD
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