Clinical trial NCT06801067: A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diarrhea
Enterocolitis
Keywords: Diarrhea
SER-155
Enterocolitis
Memorial Sloan Kettering Cancer Center
24-231
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Proportion of participants with treatment-related adverse events of special interest
timeFrame: 1 year
measure: Proportion of patients with treatment-related adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15
timeFrame: Day 15
measure: Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15
timeFrame: Day 15
measure: Proportion of patients with immunosuppressive-free clinical response of irEC at day 43
timeFrame: Day 43
measure: Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43
timeFrame: Day 43
measure: Time to immunosuppressive-free clinical response
timeFrame: 1 year
measure: Time to immunosuppressive-free clinical remission
timeFrame: 1 year
measure: Number of detectable SER-155 strains at day 15
timeFrame: Day 15
measure: Number of detectable SER-155 strains at day 43
timeFrame: Day 43
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited protocol activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Faleck, MD
role: PRINCIPAL_INVESTIGATOR
References: