Using SER-155 to treat diarrhea in patients receiving 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
This study is testing if a new medication called SER-155 can help adults with severe diarrhea caused by immunotherapy feel better with fewer side effects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | infliximab, vedolizumab, ustekinumab, chemotherapy, Prednisone |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06801067 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and efficacy of SER-155 as a treatment for diarrhea caused by immunotherapy-related enterocolitis. Participants will be adults over 18 who have experienced grade 2-3 diarrhea linked to immune checkpoint inhibitors within the last 180 days. The study will assess whether SER-155 can provide relief with minimal side effects. Eligible patients will receive the oral medication and will be monitored for their response to treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have experienced significant diarrhea related to immunotherapy.
Not a fit: Patients with active gastrointestinal infections or those not experiencing diarrhea related to immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from diarrhea due to immunotherapy.
How similar studies have performed: While the specific use of SER-155 is novel, similar approaches targeting diarrhea in immunotherapy patients have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: David Faleck, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: David Faleck, MD
- Email: faleckd@mskcc.org
- Phone: 212-639-8286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.