NCT06801067招募中1 期
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
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 7
- 主要终点
- Proportion of patients with treatment-related adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment.
排除标准
- •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
研究组 & 干预措施
Participants with Immune checkpoint inhibitor-related enterocolitis (irEC)
Experimental
Participants with grade 2-3 diarrhea from irEC who have not yet received immunosuppressive therapy for irEC
干预措施: SER-155 (Biological)
结局指标
主要结局
Proportion of patients with treatment-related adverse events
时间窗: 1 year
Proportion of patients with treatment-related adverse events
Proportion of participants with treatment-related adverse events of special interest
时间窗: 1 year
Proportion of participants with treatment-related adverse events of special interest, i.e. blood stream infection
次要结局
- Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15(Day 15)
- Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15(Day 15)
- Proportion of patients with immunosuppressive-free clinical response of irEC at day 43(Day 43)
- Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43(Day 43)
- Time to immunosuppressive-free clinical response(1 year)
- Time to immunosuppressive-free clinical remission(1 year)
- Number of detectable SER-155 strains at day 15(Day 15)
- Number of detectable SER-155 strains at day 43(Day 43)
研究者
研究点 (7)
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