[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505486":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":470,"collaborators":24,"id":472,"slug":473,"hasResults":474,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":24,"eligibilityCriteria":478,"healthyVolunteers":474,"sex":479,"minAge":480,"maxAge":24,"enrollmentInfo":481,"targetDuration":24,"studyType":484,"phases":485,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":504},{"fullName":5,"class":6},"Ichnos Sciences SA","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Dose Escalation","EXPERIMENTAL","Participants with R\u002FR MM is administered ISB 2001 weekly on Days 1, 8, 15, and 22 of each 28-day cycle, with an additional step-up dose in Cycle 1 on Day 4. Treatment cycle duration is 28 days. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study",[13],"Drug: ISB 2001",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2: Dose Expansion","Dose expansion cohorts are initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study.",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","ISB 2001","Participants receive escalating doses of ISB 2001",[9],null,{"type":20,"name":21,"description":26,"armGroupLabels":27,"otherNames":24},"Participants receive injection of ISB 2001 as determined in Part 1.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Ichnos Sciences Clinical Trials Administrator","CONTACT","(315) 583-1249","clinicaltrials@ichnossciences.com",[35,54,65,80,95,110,125,140,150,160,175,192,206,221,235,250,267,282,296,311,323,333,343,353,358,370,384,400,417,432,446,455],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Standford Cancer Institute","RECRUITING","Palo 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Hospital","Benowa","Queensland","4217",{"type":44,"coordinates":198},[199,200],153.38583,-28.0077,{"lat":200,"lon":199},[203],{"name":204,"role":31,"phone":24,"phoneExt":24,"email":205},"Hanlon Sia, MBBS(Adelaide), FRACP, FRCPA","drsia@fiho.com.au",{"facility":207,"status":37,"city":208,"state":209,"zip":210,"country":180,"countryCode":181,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"St. Vincent's Hospital Melbourne","Fitzroy","Victoria","3065",{"type":44,"coordinates":212},[213,214],144.97833,-37.79839,{"lat":214,"lon":213},[217],{"name":218,"role":31,"phone":219,"phoneExt":24,"email":220},"Hang Quach","03 9231 2003","hang.quach@svha.org.au",{"facility":222,"status":37,"city":223,"state":209,"zip":224,"country":180,"countryCode":181,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Peter MacCallum Cancer 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Lille","Lille","Hauts-de-France","59800","France","FR",{"type":44,"coordinates":258},[259,260],3.05512,50.63391,{"lat":260,"lon":259},[263],{"name":264,"role":31,"phone":265,"phoneExt":24,"email":266},"Salomon Manier, MD","+33-320444292","salomon.manier@chru-lille.fr",{"facility":268,"status":37,"city":269,"state":270,"zip":271,"country":255,"countryCode":256,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"CHU Poiters - Hospital la Miletrie","Poitiers","New Aquitaine","86021",{"type":44,"coordinates":273},[274,275],0.34348,46.58261,{"lat":275,"lon":274},[278],{"name":279,"role":31,"phone":280,"phoneExt":24,"email":281},"Xavier Leleu, MD","+33-240083271","xavier.leleu@chu-poitiers.fr",{"facility":283,"status":37,"city":284,"state":285,"zip":286,"country":255,"countryCode":256,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"CHU de Nantes - Hotel Dieu","Nantes","Pays de la Loire 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Policlinico","Milan","20122",{"type":44,"coordinates":375},[376,377],9.18951,45.46427,{"lat":377,"lon":376},[380],{"name":381,"role":31,"phone":382,"phoneExt":24,"email":383},"Matteo Da Via","+39-255033421","matteo.davia@policlinico.mi.it",{"facility":385,"status":37,"city":386,"state":386,"zip":387,"country":388,"countryCode":389,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Oslo University Hospital","Oslo","0372","Norway","NO",{"type":44,"coordinates":391},[392,393],10.74609,59.91273,{"lat":393,"lon":392},[396],{"name":397,"role":31,"phone":398,"phoneExt":24,"email":399},"Fredrik Schjesvild, MD","+47-02770","fredrikschjesvold@gmail.com",{"facility":401,"status":37,"city":402,"state":403,"zip":404,"country":405,"countryCode":406,"cosmosGeoPoint":407,"geoPoint":411,"contacts":412},"Instituto de Investigacion Biomedica de Salamanca (IBSAL)","Salamanca","Castile de Leon","37007","Spain","ES",{"type":44,"coordinates":408},[409,410],-5.66388,40.96882,{"lat":410,"lon":409},[413],{"name":414,"role":31,"phone":415,"phoneExt":24,"email":416},"Maria-Victoria Mateos, MD","+34-923291100","mvmateos@usal.es",{"facility":418,"status":37,"city":419,"state":420,"zip":421,"country":405,"countryCode":406,"cosmosGeoPoint":422,"geoPoint":426,"contacts":427},"Institut Catala de Oncologia (ICO)","Badalona","Catalonia","08916",{"type":44,"coordinates":423},[424,425],2.24741,41.45004,{"lat":425,"lon":424},[428],{"name":429,"role":31,"phone":430,"phoneExt":24,"email":431},"Laura Abril, MD","+34-934978706","labril@iconcologia.net",{"facility":433,"status":37,"city":434,"state":420,"zip":435,"country":405,"countryCode":406,"cosmosGeoPoint":436,"geoPoint":440,"contacts":441},"Hospital Clinic de Barcelona","Barcelona","08036",{"type":44,"coordinates":437},[438,439],2.15899,41.38879,{"lat":439,"lon":438},[442],{"name":443,"role":31,"phone":444,"phoneExt":24,"email":445},"Laura Rosinol, MD","+34-932275428","lrosinol@clinic.cat",{"facility":447,"status":56,"city":448,"state":448,"zip":449,"country":405,"countryCode":406,"cosmosGeoPoint":450,"geoPoint":454,"contacts":24},"Centro Integral Oncologici Clara Campal","Madrid","28050",{"type":44,"coordinates":451},[452,453],-3.70256,40.4165,{"lat":453,"lon":452},{"facility":456,"status":37,"city":457,"state":458,"zip":459,"country":405,"countryCode":406,"cosmosGeoPoint":460,"geoPoint":464,"contacts":465},"Clinica Universidad de Nevarra","Pamplona","Navarre","31008",{"type":44,"coordinates":461},[462,463],-1.64323,42.81687,{"lat":463,"lon":462},[466],{"name":467,"role":31,"phone":468,"phoneExt":24,"email":469},"Paula Rodriguez Otero, MD","+34-948296397","paurodriguez@unav.es",{"type":471,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100505486","phase-1-study-of-isb-2001-in-relapsedrefractory-multiple-myeloma-trignite-1-100505486",false,"NCT05862012","Study of ISB 2001 in Relapsed\u002FRefractory Multiple Myeloma (TRIgnite-1)","A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Participants with pathologically confirmed MM with measurable M-protein: serum and\u002For 24 hour urine, serum-free light chains or measurable isolated plasmacytoma\n2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less\n3. Must have adequate hematologic, hepatic, renal, and cardiac functions\n\nExclusion Criteria:\n\n1. Active malignant central nervous system involvement\n2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1\n3. History of autoimmune disease requiring systemic immunosuppressive therapy\n4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.\n5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.","ALL","18 Years",{"count":482,"type":483},200,"ESTIMATED","INTERVENTIONAL",[486],"PHASE1","This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed\u002Frefractory multiple myeloma (R\u002FR MM).",[489],"Relapsed\u002FRefractory Multiple Myeloma",[21,491,492,493,494],"Relapsed\u002Frefractory multiple myeloma","Open-label","Dose escalation","Dose expansion","2026-03-31",{"date":497,"type":498},"2026-04-01","ACTUAL",{"date":500,"type":498},"2023-11-01",{"date":502,"type":483},"2027-07",{"name":5,"class":6},32]