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RecruitingInterventionalPhase 1

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

NCT ID: NCT06801067Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2025-12-02

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.

Arms & interventions

  • BiologicalSER-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

Outcome measures

Primary

  • 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

    Time frame: 1 year

  • Proportion of patients with treatment-related adverse events

    Proportion of patients with treatment-related adverse events

    Time frame: 1 year

Secondary

  • Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15

    Time frame: Day 15

  • Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15

    Time frame: Day 15

  • Proportion of patients with immunosuppressive-free clinical response of irEC at day 43

    Time frame: Day 43

  • Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43

    Time frame: Day 43

  • Time to immunosuppressive-free clinical response

    Time frame: 1 year

  • Time to immunosuppressive-free clinical remission

    Time frame: 1 year

  • Number of detectable SER-155 strains at day 15

    Time frame: Day 15

  • Number of detectable SER-155 strains at day 43

    Time frame: Day 43

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Study locations (7)

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
David Faleck, MD · Contact

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
David Faleck, MD · Contact

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
David Faleck, MD · Contact

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, 11725

Recruiting
David Faleck, MD · Contact

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

Recruiting
David Faleck, MD · Contact

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
David Faleck, MD · Contact

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553

Recruiting
David Faleck, MD · Contact