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New treatment option for Diarrhea
Official title A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
ClinicalTrials.gov ID: NCT06801067
What this study is testing
What is SER-155?
SER-155 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for diarrhea.
Also referred to as Cultivated Multi-Strain Live Bacterial Therapeutic, Encapsulated.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years
- Receipt of ICI (single-agent or combination) within the 180 days preceding screening. Concurrent treatment with cytotoxic chemotherapy or other...
- 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...
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.