A Study of SER-155 to Treat Diarrhea in People on Immunotherapy

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06801067
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diarrhea
  • Enterocolitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SER-155 — BIOLOGICAL
    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

Study Details

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.

Key Dates

Start date
Jan 24, 2025
Status verified
Oct 2025
Primary completion
Jan 24, 2027
Completion
Jan 24, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with Immune checkpoint inhibitor-related enterocolitis (irEC)
    Participants with grade 2-3 diarrhea from irEC who have not yet received immunosuppressive therapy for irEC

Primary Outcome Measure

Proportion of participants with treatment-related adverse events of special interest [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
David Faleck, MD
212-639-8286
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
David Faleck, MD
212-639-8286
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
David Faleck, MD
212-639-8286
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)CommackNew York11725
David Faleck, MD
212-639-8286
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
David Faleck, MD
212-639-8286
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
David Faleck, MD
212-639-8286
Memorial Sloan Kettering Nassau (Limited protocol activities)Rockville CentreNew York11553
David Faleck, MD
212-639-8286

Find similar trials in Basking Ridge, NJ

By research site
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (All Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Limited protocol activity)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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