RecruitingPhase 1NCT06801067

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

15 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

Diarrhea Enterocolitis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria13

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

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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