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Recruiting NCT06801067

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

Phase I Interventional Diarrhea Enterocolitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SER-155.
Who it may be relevant to
Registry conditions: Diarrhea, Enterocolitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

Interventions

  • Biological 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

Primary outcome measures

  • Proportion of participants with treatment-related adverse events of special interest [Time frame: 1 year]
  • Proportion of patients with treatment-related adverse events [Time frame: 1 year]
Secondary outcome measures (8)
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre

Identifiers

NCT: NCT06801067 · 24-231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗