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Идёт набор NCT06801067

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

Фаза I С лечением Diarrhea Enterocolitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SER-155.
Кому может быть актуально
Состояния в реестре: Diarrhea, Enterocolitis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Биопрепарат 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

Первичные конечные точки

  • Proportion of participants with treatment-related adverse events of special interest [Срок оценки: 1 year]
  • Proportion of patients with treatment-related adverse events [Срок оценки: 1 year]
Вторичные конечные точки (8)
  • Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15 [Срок оценки: Day 15]
  • Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15 [Срок оценки: Day 15]
  • Proportion of patients with immunosuppressive-free clinical response of irEC at day 43 [Срок оценки: Day 43]
  • Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43 [Срок оценки: Day 43]
  • Time to immunosuppressive-free clinical response [Срок оценки: 1 year]
  • Time to immunosuppressive-free clinical remission [Срок оценки: 1 year]
  • Number of detectable SER-155 strains at day 15 [Срок оценки: Day 15]
  • Number of detectable SER-155 strains at day 43 [Срок оценки: Day 43]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 7 центров
  • 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

Идентификаторы

NCT: NCT06801067 · 24-231

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗