NCT06801067PHASE1Recruiting
A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
Memorial Sloan Kettering Cancer Center
Start Date
1/24/2025
Completion Date
1/24/2027
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 Criteria
Age Range: 18 years to No maximum
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
Interventions
BIOLOGICAL
SER-155
Conditions
DiarrheaEnterocolitis
Locations
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York 11553
United States