A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
A Single-Arm, Open-Label, Phase 1 Study to Assess Safety and Preliminary Efficacy of Cultivated Multi-Strain Live Bacterial Therapeutic SER-155 for First-Line Treatment of Immunotherapy-Related Enterocolitis
1 other identifier
interventional
15
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2025
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2025
CompletedStudy Start
First participant enrolled
January 24, 2025
CompletedFirst Posted
Study publicly available on registry
January 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 24, 2027
December 2, 2025
October 1, 2025
2 years
January 24, 2025
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of participants with treatment-related adverse events of special interest
Proportion of participants with treatment-related adverse events of special interest, i.e. blood stream infection
1 year
Proportion of patients with treatment-related adverse events
Proportion of patients with treatment-related adverse events
1 year
Secondary Outcomes (8)
Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15
Day 15
Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15
Day 15
Proportion of patients with immunosuppressive-free clinical response of irEC at day 43
Day 43
Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43
Day 43
Time to immunosuppressive-free clinical response
1 year
- +3 more secondary outcomes
Study Arms (1)
Participants with Immune checkpoint inhibitor-related enterocolitis (irEC)
EXPERIMENTALParticipants with grade 2-3 diarrhea from irEC who have not yet received immunosuppressive therapy for irEC
Interventions
SER-155 (Cultivated Multi-Strain Live Bacterial Therapeutic, Encapsulated) is an experimental designed ecology of 16 unique, human-commensal bacterial strains encapsulated for oral administration and will be provided by Seres as an investigational drug
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Faleck, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2025
First Posted
January 30, 2025
Study Start
January 24, 2025
Primary Completion (Estimated)
January 24, 2027
Study Completion (Estimated)
January 24, 2027
Last Updated
December 2, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.