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
Memorial Sloan Kettering Cancer Center
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…