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

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

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

Conditions3

Locations7 sites

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