A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
NCT ID: NCT06801067
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2025-01-24
2027-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants with Immune checkpoint inhibitor-related enterocolitis (irEC)
Participants with grade 2-3 diarrhea from irEC who have not yet received immunosuppressive therapy for irEC
SER-155
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
Interventions
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SER-155
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Faleck, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Facility Contacts
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David Faleck, MD
Role: primary
David Faleck, MD
Role: primary
David Faleck, MD
Role: primary
David Faleck, MD
Role: primary
David Faleck, MD
Role: primary
David Faleck, MD
Role: primary
David Faleck, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-231
Identifier Type: -
Identifier Source: org_study_id
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