Trials / Recruiting
RecruitingNCT06801067
A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SER-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 |
Timeline
- Start date
- 2025-01-24
- Primary completion
- 2027-01-24
- Completion
- 2027-01-24
- First posted
- 2025-01-30
- Last updated
- 2025-12-02
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06801067. Inclusion in this directory is not an endorsement.