A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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
Qualifiers
Age > 18 years
Receipt of ICI (single-agent or combination) within the 180 days preceding screening.
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.
Able to swallow oral medication
Disqualifiers
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
Trial design
Treatments tested in this trial
- SER-155
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov