Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT06801067
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D004760', 'term': 'Enterocolitis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-01-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with treatment-related adverse events of special interest', 'timeFrame': '1 year', 'description': 'Proportion of participants with treatment-related adverse events of special interest, i.e. blood stream infection'}, {'measure': 'Proportion of patients with treatment-related adverse events', 'timeFrame': '1 year', 'description': 'Proportion of patients with treatment-related adverse events'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15', 'timeFrame': 'Day 15', 'description': 'Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15, defined as at least one grade decrease in diarrhea symptoms without the use of immunosuppressive therapy'}, {'measure': 'Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15', 'timeFrame': 'Day 15', 'description': 'Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15, defined as resolution in diarrhea symptoms (grade 0) without the use of immunosuppressive therapy'}, {'measure': 'Proportion of patients with immunosuppressive-free clinical response of irEC at day 43', 'timeFrame': 'Day 43', 'description': 'Proportion of patients with immunosuppressive-free clinical response of irEC at day 43'}, {'measure': 'Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43', 'timeFrame': 'Day 43', 'description': 'Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43'}, {'measure': 'Time to immunosuppressive-free clinical response', 'timeFrame': '1 year', 'description': 'Time to immunosuppressive-free clinical response'}, {'measure': 'Time to immunosuppressive-free clinical remission', 'timeFrame': '1 year', 'description': 'Time to immunosuppressive-free clinical remission'}, {'measure': 'Number of detectable SER-155 strains at day 15', 'timeFrame': 'Day 15', 'description': 'Number of detectable SER-155 strains at day 15'}, {'measure': 'Number of detectable SER-155 strains at day 43', 'timeFrame': 'Day 43', 'description': 'Number of detectable SER-155 strains at day 43'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diarrhea', 'SER-155', 'Enterocolitis', 'Memorial Sloan Kettering Cancer Center', '24-231'], 'conditions': ['Diarrhea', 'Enterocolitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years\n* Receipt of ICI (single-agent or combination) within the 180 days preceding screening.\n\nConcurrent treatment with cytotoxic chemotherapy or other tumor-directed agents is permitted.\n\n* 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.\n\nabdominal pain, bloody or mucoid stools)\n\n* Able to swallow oral medication\n* 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.\n* Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment.\n\nExclusion Criteria:\n\n* Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea.\n* Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and/or infliximab, vedolizumab or ustekinumab\n* Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs\n* Admitted to the hospital for irEC\n* Prednisone (or steroid equivalent) dose \\> 10 mg a day for a non-GI irAE at time of screening\n* Pre-existing inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or microscopic colitis\n* Pregnant or lactating women\n* Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics\n* Severe neutropenia, as defined by an absolute neutrophil count (ANC) \\< 500 cells/mm\\^3, at time of screening\n* Treatment with investigational medications used for diarrhea/colitis treatment and microbiome therapeutics within 30 days prior to enrollment\n* Known allergy or intolerance to oral vancomycin\n* Unable to comply with the protocol requirements\n* 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"}, 'identificationModule': {'nctId': 'NCT06801067', 'briefTitle': 'A Study of SER-155 to Treat Diarrhea in People on Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '24-231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with Immune checkpoint inhibitor-related enterocolitis (irEC)', 'description': 'Participants with grade 2-3 diarrhea from irEC who have not yet received immunosuppressive therapy for irEC', 'interventionNames': ['Biological: SER-155']}], 'interventions': [{'name': 'SER-155', 'type': 'BIOLOGICAL', 'otherNames': ['Cultivated Multi-Strain Live Bacterial Therapeutic, Encapsulated'], 'description': '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', 'armGroupLabels': ['Participants with Immune checkpoint inhibitor-related enterocolitis (irEC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Faleck, MD', 'role': 'CONTACT', 'phone': '212-639-8286'}], 'facility': 'Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Faleck, MD', 'role': 'CONTACT', 'phone': '212-639-8286'}], 'facility': 'Memorial Sloan Kettering Monmouth (All Protocol Activities)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Faleck, MD', 'role': 'CONTACT', 'phone': '212-639-8286'}], 'facility': 'Memorial Sloan Kettering Bergen (All Protocol Activities)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Faleck, MD', 'role': 'CONTACT', 'phone': '212-639-8286'}], 'facility': 'Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Faleck, MD', 'role': 'CONTACT', 'phone': '212-639-8286'}], 'facility': 'Memorial Sloan Kettering Westchester (Limited Protocol Activities)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Faleck, MD', 'role': 'CONTACT', 'phone': '212-639-8286'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activities)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Rockville Centre', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Faleck, MD', 'role': 'CONTACT', 'phone': '212-639-8286'}], 'facility': 'Memorial Sloan Kettering Nassau (Limited protocol activities)', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'centralContacts': [{'name': 'David Faleck, MD', 'role': 'CONTACT', 'email': 'faleckd@mskcc.org', 'phone': '212-639-8286'}, {'name': 'Michael Postow, MD', 'role': 'CONTACT', 'email': 'PostowM@mskcc.org', 'phone': '646-888-4315'}], 'overallOfficials': [{'name': 'David Faleck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}