Actively Recruiting
A Study to Assess Safety and Preliminary Efficacy of SER-155 for First-Line Treatment of Immunotherapy-Related Enterocolitis Diarrhea
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-02
15
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SER-155, an experimental live bacterial therapeutic, as a first treatment option for people experiencing diarrhea due to immunotherapy-related enterocolitis (irEC). The study is a phase 1, open-label trial focused on assessing the safety and initial effectiveness of SER-155 in this group. This research is sponsored by Memorial Sloan Kettering Cancer Center and aims to find out if SER-155 causes few or mild side effects when used as a first treatment for irEC. Participants with grade 2-3 diarrhea from irEC who have not yet received immunosuppressive therapy for their condition will take SER-155 orally. This therapy consists of 16 unique bacterial strains encapsulated for oral use. The study will monitor participants over time to observe safety and preliminary efficacy, including responses and remission without the need for immunosuppressive drugs at days 15 and 43, as well as tracking the presence of SER-155 strains in stool samples. During the study, participants will be evaluated for treatment-related adverse events for up to one year. Researchers will also assess their clinical response and remission status at specific time points, monitor bacterial strain levels, and record the time to response or remission without immunosuppressive therapy. Participants will provide informed consent and comply with study protocols, including swallowing oral medication and using contraception if applicable. The total participation duration includes assessments up to one year after treatment begins.
CONDITIONS
Brief Title
A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Received immune checkpoint inhibitor therapy within 180 days before screening
- Grade 2 - 3 diarrhea likely related to immunotherapy, with or without mild colitis symptoms
- Able to swallow oral medication
- Individuals of childbearing potential willing to use effective contraception for 30 days after last dose
- Willing to provide informed consent and comply with study requirements
You will not qualify if you...
- Active gastrointestinal infection causing diarrhea
- Previous immunosuppressive treatment for immunotherapy-related enterocolitis
- Severe colitis symptoms such as severe abdominal pain or peritoneal signs
- Hospitalization for immunotherapy-related enterocolitis
- Taking prednisone dose > 10 mg daily for non-GI immune adverse events at screening
- Pre-existing inflammatory bowel disease or microscopic colitis
- Pregnant or lactating women
- Need for ongoing antibacterial antibiotics
- Severe neutropenia (ANC < 500 cells/mm3) at screening
- Treatment with investigational diarrhea or microbiome therapies within 30 days prior
- Known allergy or intolerance to oral vancomycin
- Unable to comply with protocol requirements
- Any condition increasing risk or interfering with study results as judged by investigator
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 - Up to 43 days
Participants receive the investigational drug SER-155 to treat immunotherapy-related enterocolitis diarrhea.
Visits occur at baseline, day 15, and day 43
Trial Site Locations
Total: 7 locations
1
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
D
David Faleck, MD
M
Michael Postow, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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