What is SER-155 studying for diarrhea related to immunotherapy?

SER-155 is being studied as a potential first treatment for diarrhea caused by immunotherapy-related enterocolitis. Researchers want to assess its safety and whether it can help with symptoms without using immunosuppressive drugs. The study is led by Memorial Sloan Kettering Cancer Center and focuses on people experiencing this side effect from cancer treatments.

Who may be eligible for this diarrhea and enterocolitis clinical trial?

Adults aged 18 years or older who have received immune checkpoint inhibitor therapy within the last 180 days and have grade 2 or 3 diarrhea related to immunotherapy may be eligible. Participants must be able to swallow oral medication and have not received immunosuppressive therapy for this condition. Please review eligibility criteria for more details.

Is there any cost to participate in this diarrhea clinical trial?

Study-related care, including the investigational drug SER-155 and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should consider these factors when joining the trial.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID06801067

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

Participants Needed

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age > 18 years
Received immune checkpoint inhibitor therapy within 180 days before screening
Grade 2 to 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 protocol

You will not qualify if you...

Active gastrointestinal infection causing diarrhea
Prior immunosuppressive therapy for immunotherapy-related enterocolitis
Severe colitis symptoms such as severe abdominal pain or peritoneal signs
Hospitalization for immunotherapy-related enterocolitis
Prednisone dose over 10 mg daily for non-gastrointestinal adverse events at screening
Pre-existing inflammatory bowel disease or microscopic colitis
Pregnant or breastfeeding women
Need for ongoing antibacterial antibiotics
Severe neutropenia (absolute neutrophil count < 500 cells/mm³) at screening
Use of investigational diarrhea or microbiome treatments within 30 days prior
Known allergy or intolerance to oral vancomycin
Unable to comply with study requirements
Any condition increasing risk or interfering with study results as judged by investigator

Research Team

David Faleck, MD

Michael Postow, MD

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