RECRUITING

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

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Conditions

DiarrheaEnterocolitisSER-155Memorial Sloan Kettering Cancer Center24-231

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-24
Study Completion:2027-01-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06801067

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years
  2. * Receipt of ICI (single-agent or combination) within the 180 days preceding screening.
  3. * 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.
  4. * Able to swallow oral medication
  5. * 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.
  6. * Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment.
  1. * Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea.
  2. * Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and/or infliximab, vedolizumab or ustekinumab
  3. * Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs
  4. * Admitted to the hospital for irEC
  5. * Prednisone (or steroid equivalent) dose \> 10 mg a day for a non-GI irAE at time of screening
  6. * Pre-existing inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or microscopic colitis
  7. * Pregnant or lactating women
  8. * Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics
  9. * Severe neutropenia, as defined by an absolute neutrophil count (ANC) \< 500 cells/mm\^3, at time of screening
  10. * Treatment with investigational medications used for diarrhea/colitis treatment and microbiome therapeutics within 30 days prior to enrollment
  11. * Known allergy or intolerance to oral vancomycin
  12. * Unable to comply with the protocol requirements
  13. * 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

Contacts and Locations

Study Contact

David Faleck, MD
CONTACT
212-639-8286
faleckd@mskcc.org
Michael Postow, MD
CONTACT
646-888-4315
PostowM@mskcc.org

Principal Investigator

David Faleck, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-24
Study Completion Date2027-01-24

Study Record Updates

Study Start Date2025-01-24
Study Completion Date2027-01-24

Terms related to this study

Keywords Provided by Researchers

  • Diarrhea
  • SER-155
  • Enterocolitis
  • Memorial Sloan Kettering Cancer Center
  • 24-231

Additional Relevant MeSH Terms

  • Diarrhea
  • Enterocolitis