A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
Recruiting now · Phase 1
Conditions studied: Diarrhea, Enterocolitis
In brief
The purpose of this study is to find out whether SER-155 may be a safe first treatment that causes few or mild side effects for people due to irEC.
Key facts
- Study ID
- NCT06801067
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 15
- Starts
- 2025-01-24
- Expected to finish
- 2027-01-24
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years
- Receipt of ICI (single-agent or combination) within the 180 days preceding screening.
- Concurrent treatment with cytotoxic chemotherapy or other tumor-directed agents is permitted.
- Grade 2 - 3 diarrhea (i.e., increase of at least 4 bowel movements a day above baseline during the screening window), deemed by the treating provider as likely related to ICI therapy, with or without concomitant symptoms of grade 1 - 2 colitis (e.g.
- abdominal pain, bloody or mucoid stools)
- Able to swallow oral medication
- Individuals of childbearing potential willing to use a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) for 30 days after the last dose of SER-155.
- Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment.
You may not qualify if…
- Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea.
- Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and/or infliximab, vedolizumab or ustekinumab
- Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs
- Admitted to the hospital for irEC
- Prednisone (or steroid equivalent) dose > 10 mg a day for a non-GI irAE at time of screening
- Pre-existing inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or microscopic colitis
- Pregnant or lactating women
- Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics
- Severe neutropenia, as defined by an absolute neutrophil count (ANC) < 500 cells/mm\^3, at time of screening
- Treatment with investigational medications used for diarrhea/colitis treatment and microbiome therapeutics within 30 days prior to enrollment
- Known allergy or intolerance to oral vancomycin
- Unable to comply with the protocol requirements
- Any condition that in the opinion of the investigator may increase the risk of study participation and/or may interfere with the interpretation of study results
Where it is running
- Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack, New York, United States (enrolling)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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