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
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.
Arms & interventions
- BiologicalSER-155
SER-155 (Cultivated Multi-Strain Live Bacterial Therapeutic, Encapsulated) is an experimental designed ecology of 16 unique, human-commensal bacterial strains encapsulated for oral administration and will be provided by Seres as an investigational drug
Outcome measures
Primary
Proportion of participants with treatment-related adverse events of special interest
Proportion of participants with treatment-related adverse events of special interest, i.e. blood stream infection
Time frame: 1 year
Proportion of patients with treatment-related adverse events
Proportion of patients with treatment-related adverse events
Time frame: 1 year
Secondary
Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15
Time frame: Day 15
Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15
Time frame: Day 15
Proportion of patients with immunosuppressive-free clinical response of irEC at day 43
Time frame: Day 43
Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43
Time frame: Day 43
Time to immunosuppressive-free clinical response
Time frame: 1 year
Time to immunosuppressive-free clinical remission
Time frame: 1 year
Number of detectable SER-155 strains at day 15
Time frame: Day 15
Number of detectable SER-155 strains at day 43
Time frame: Day 43
Eligibility criteria
Study locations (7)
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553