A Study of SER-155 to Treat Diarrhea in People on Immunotherapy

Description

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.

Conditions

Diarrhea, Enterocolitis

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Study Overview

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Study Details

Study overview

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.

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

A Study of SER-155 to Treat Diarrhea in People on Immunotherapy

Condition
Diarrhea
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States, 10065

Rockville Centre

Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age \> 18 years
  • * Receipt of ICI (single-agent or combination) within the 180 days preceding screening.
  • * 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.
  • * 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

David Faleck, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2027-01-24