[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05862012":3,"trial-entities:NCT05862012":468,"trial-summary:NCT05862012":472},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":43,"secondary_outcomes":50,"sex":79,"minimum_age":80,"maximum_age":15,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":86,"locations":89,"central_contacts":453,"overall_officials":458,"references":459,"see_also_links":467},"NCT05862012","ISB 2001-101","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","RECRUITING","2027-07","2026-03","2026-04-01","2023-11-01","Ichnos Sciences SA","INDUSTRY",null,"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).","The study enrolls participants with R\u002FR MM that have been treated with immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in MM.\n\nThe study is conducted in two parts: Part 1 dose escalation and Part 2 dose expansion.\n\nDose escalation continued until the maximum planned dose was reached. Dose expansion cohorts were initiated to further confirm safety and optimal biologically active dose. Participants receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.",[19],"Relapsed\u002FRefractory Multiple Myeloma",[21,22,23,24,25],"ISB 2001","Relapsed\u002Frefractory multiple myeloma","Open-label","Dose escalation","Dose expansion","INTERVENTIONAL","TREATMENT",[29],"PHASE1",{"count":31,"type":32},200,"ESTIMATED",[34,39],{"type":35,"name":21,"description":36,"armGroupLabels":37},"DRUG","Participants receive escalating doses of ISB 2001",[38],"Part 1: Dose Escalation",{"type":35,"name":21,"description":40,"armGroupLabels":41},"Participants receive injection of ISB 2001 as determined in Part 1.",[42],"Part 2: Dose Expansion",[44,47],{"measure":45,"timeFrame":46},"Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)","Up to 18 months",{"measure":48,"timeFrame":49},"Number of Dose-Limiting Toxicities (DLT) During the First 28 Days After the First Administration of ISB 2001 (Cycle 1) in Each Cohort (Part 1)","Up to 28 days",[51,53,55,57,59,62,65,67,69,71,73,75,77],{"measure":52,"timeFrame":49},"Maximum Concentration (Cmax) of ISB 2001 in Serum",{"measure":54,"timeFrame":49},"Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum",{"measure":56,"timeFrame":49},"Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum",{"measure":58,"timeFrame":49},"Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum",{"measure":60,"timeFrame":61},"Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT)","Baseline to 18 months",{"measure":63,"timeFrame":64},"Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)","18 months",{"measure":66,"timeFrame":64},"Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)",{"measure":68,"timeFrame":64},"Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)",{"measure":70,"timeFrame":64},"Time to Progression (TTP)",{"measure":72,"timeFrame":64},"Time to Next Treatment (TTNT)",{"measure":74,"timeFrame":64},"Time to Response (TTR)",{"measure":76,"timeFrame":64},"Progression Free Survival (PFS)",{"measure":78,"timeFrame":64},"Overall Survival (OS)","ALL","18 Years",false,{"inclusion":83,"exclusion":84,"raw_text":85},[],[],"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.",[87,88],"ADULT","OLDER_ADULT",[90,105,114,127,140,153,166,179,187,195,208,222,234,247,259,272,286,299,311,324,333,341,349,357,360,369,381,394,408,421,433,440],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":102},"Standford Cancer Institute","Palo Alto","California","94304","United States",[97],{"name":98,"role":99,"phone":100,"email":101},"Michaela Liedtke","CONTACT","650-723-0501","mliedtke@stanford.edu",{"lat":103,"lon":104},37.44188,-122.14302,{"facility":106,"status":107,"city":108,"state":109,"zip":110,"country":95,"geoPoint":111},"Sylvester Cancer Center","ACTIVE_NOT_RECRUITING","Miami","Florida","33136",{"lat":112,"lon":113},25.77427,-80.19366,{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":95,"contacts":119,"geoPoint":124},"Winship Cancer Institute","Atlanta","Georgia","30322",[120],{"name":121,"role":99,"phone":122,"email":123},"Nishi Shah, MD","404-778-0659","nishi.nilesh@emory.edu",{"lat":125,"lon":126},33.749,-84.38798,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":95,"contacts":132,"geoPoint":137},"University of Chicago Medical Center","Chicago","Illinois","60637",[133],{"name":134,"role":99,"phone":135,"email":136},"Benjamin Derman, MD","8472758131","bendermanmd@gmail.com",{"lat":138,"lon":139},41.85003,-87.65005,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":95,"contacts":145,"geoPoint":150},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",[146],{"name":147,"role":99,"phone":148,"email":149},"Shonali Midha, MD","617-632-2104","shonali_midha@dfci.harvard.edu",{"lat":151,"lon":152},42.35843,-71.05977,{"facility":154,"status":8,"city":155,"state":156,"zip":157,"country":95,"contacts":158,"geoPoint":163},"Montefiore Medical Center","The Bronx","New York","10467",[159],{"name":160,"role":99,"phone":161,"email":162},"David Levitz","860-918-6192","dlevitz@montefiore.org",{"lat":164,"lon":165},40.84985,-73.86641,{"facility":167,"status":8,"city":168,"state":169,"zip":170,"country":95,"contacts":171,"geoPoint":176},"University of North Carolina","Chapel Hill","North Carolina","27599",[172],{"name":173,"role":99,"phone":174,"email":175},"Eben Lichtman","6178426051","eben_lichtman@med.unc.edu",{"lat":177,"lon":178},35.9132,-79.05584,{"facility":180,"status":107,"city":181,"state":182,"zip":183,"country":95,"geoPoint":184},"Tennessee Oncology","Nashville","Tennessee","37203",{"lat":185,"lon":186},36.16589,-86.78444,{"facility":188,"status":107,"city":189,"state":190,"zip":191,"country":95,"geoPoint":192},"Virginia Commonwealth University (VCU)","Richmond","Virginia","23298",{"lat":193,"lon":194},37.55376,-77.46026,{"facility":196,"status":8,"city":197,"state":198,"zip":199,"country":95,"contacts":200,"geoPoint":205},"Froedtert Hospital & the Medical College of Wisconsin","Milwaukee","Wisconsin","53226",[201],{"name":202,"role":99,"phone":203,"email":204},"Binod Dhakal, MD","4148054600","bdhakal@mcw.edu",{"lat":206,"lon":207},43.0389,-87.90647,{"facility":209,"status":8,"city":210,"state":211,"zip":212,"country":213,"contacts":214,"geoPoint":219},"Concord Hospital","Concord","New South Wales","2139","Australia",[215],{"name":216,"role":99,"phone":217,"email":218},"Nicole Wong Doo","+61 2 9767 7243","nicole.wongdoo@health.nsw.gov.au",{"lat":220,"lon":221},-33.84722,151.10381,{"facility":223,"status":8,"city":224,"state":225,"zip":226,"country":213,"contacts":227,"geoPoint":231},"Pindara Private Hospital","Benowa","Queensland","4217",[228],{"name":229,"role":99,"email":230},"Hanlon Sia, MBBS(Adelaide), FRACP, FRCPA","drsia@fiho.com.au",{"lat":232,"lon":233},-28.0077,153.38583,{"facility":235,"status":8,"city":236,"state":237,"zip":238,"country":213,"contacts":239,"geoPoint":244},"St. Vincent's Hospital Melbourne","Fitzroy","Victoria","3065",[240],{"name":241,"role":99,"phone":242,"email":243},"Hang Quach","03 9231 2003","hang.quach@svha.org.au",{"lat":245,"lon":246},-37.79839,144.97833,{"facility":248,"status":8,"city":249,"state":237,"zip":250,"country":213,"contacts":251,"geoPoint":256},"Peter MacCallum Cancer Center","Melbourne","3000",[252],{"name":253,"role":99,"phone":254,"email":255},"Amit Khot","+6138559500","Amit.Khot@petermac.org",{"lat":257,"lon":258},-37.814,144.96332,{"facility":260,"status":8,"city":261,"state":262,"zip":263,"country":213,"contacts":264,"geoPoint":269},"Linear Clinical Research","Nedlands","Western Australia","6009",[265],{"name":266,"role":99,"phone":267,"email":268},"Bradley Augustston","+61 (0) 8 6382 5100","bradley.augustson@health.wa.gov.au",{"lat":270,"lon":271},-31.98184,115.8073,{"facility":273,"status":8,"city":274,"state":275,"zip":276,"country":277,"contacts":278,"geoPoint":283},"CHRU Lille","Lille","Hauts-de-France","59800","France",[279],{"name":280,"role":99,"phone":281,"email":282},"Salomon Manier, MD","+33-320444292","salomon.manier@chru-lille.fr",{"lat":284,"lon":285},50.63391,3.05512,{"facility":287,"status":8,"city":288,"state":289,"zip":290,"country":277,"contacts":291,"geoPoint":296},"CHU Poiters - Hospital la Miletrie","Poitiers","New Aquitaine","86021",[292],{"name":293,"role":99,"phone":294,"email":295},"Xavier Leleu, MD","+33-240083271","xavier.leleu@chu-poitiers.fr",{"lat":297,"lon":298},46.58261,0.34348,{"facility":300,"status":8,"city":301,"state":302,"zip":303,"country":277,"contacts":304,"geoPoint":308},"CHU de Nantes - Hotel Dieu","Nantes","Pays de la Loire Region","44093",[305],{"name":306,"role":99,"phone":294,"email":307},"Cyrille Touzeau, MD","cyrille.touzeau@chu-nantes.fr",{"lat":309,"lon":310},47.21725,-1.55336,{"facility":312,"status":8,"city":313,"state":314,"zip":315,"country":277,"contacts":316,"geoPoint":321},"Groupe Hospitalier Pitie-Salpetriere","Paris","Île-de-France Region","75013",[317],{"name":318,"role":99,"phone":319,"email":320},"Laurent Garderet, MD","+33-611010920","laurent.garderet@aphp.fr",{"lat":322,"lon":323},48.85341,2.3488,{"facility":325,"status":107,"city":326,"state":327,"zip":328,"country":329,"geoPoint":330},"Apollo Hospital International Limited","Gandhinagar","Gujarat","382428","India",{"lat":331,"lon":332},23.21667,72.68333,{"facility":334,"status":107,"city":335,"state":336,"zip":337,"country":329,"geoPoint":338},"Health Care Global Enterprises Ltd.","Bangalore","Karnataka","560027",{"lat":339,"lon":340},12.97194,77.59369,{"facility":342,"status":107,"city":343,"state":344,"zip":345,"country":329,"geoPoint":346},"Deenanath Mangeshkar Hospital and Research Centre","Pune","Maharashta","411004",{"lat":347,"lon":348},18.51957,73.85535,{"facility":350,"status":107,"city":351,"state":352,"zip":353,"country":329,"geoPoint":354},"Apollo Cancer Centers","Hyderabad","Telangana","500033",{"lat":355,"lon":356},17.38405,78.45636,{"facility":358,"status":107,"city":335,"country":329,"geoPoint":359},"HCG Hospital",{"lat":339,"lon":340},{"facility":361,"status":107,"city":362,"state":363,"zip":364,"country":365,"geoPoint":366},"ASST Spedali Civili di Brescia","Brescia","Lombardy","25123","Italy",{"lat":367,"lon":368},45.53558,10.21472,{"facility":370,"status":8,"city":371,"state":363,"zip":372,"country":365,"contacts":373,"geoPoint":378},"Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico","Milan","20122",[374],{"name":375,"role":99,"phone":376,"email":377},"Matteo Da Via","+39-255033421","matteo.davia@policlinico.mi.it",{"lat":379,"lon":380},45.46427,9.18951,{"facility":382,"status":8,"city":383,"state":383,"zip":384,"country":385,"contacts":386,"geoPoint":391},"Oslo University Hospital","Oslo","0372","Norway",[387],{"name":388,"role":99,"phone":389,"email":390},"Fredrik Schjesvild, MD","+47-02770","fredrikschjesvold@gmail.com",{"lat":392,"lon":393},59.91273,10.74609,{"facility":395,"status":8,"city":396,"state":397,"zip":398,"country":399,"contacts":400,"geoPoint":405},"Instituto de Investigacion Biomedica de Salamanca (IBSAL)","Salamanca","Castile de Leon","37007","Spain",[401],{"name":402,"role":99,"phone":403,"email":404},"Maria-Victoria Mateos, MD","+34-923291100","mvmateos@usal.es",{"lat":406,"lon":407},40.96882,-5.66388,{"facility":409,"status":8,"city":410,"state":411,"zip":412,"country":399,"contacts":413,"geoPoint":418},"Institut Catala de Oncologia (ICO)","Badalona","Catalonia","08916",[414],{"name":415,"role":99,"phone":416,"email":417},"Laura Abril, MD","+34-934978706","labril@iconcologia.net",{"lat":419,"lon":420},41.45004,2.24741,{"facility":422,"status":8,"city":423,"state":411,"zip":424,"country":399,"contacts":425,"geoPoint":430},"Hospital Clinic de Barcelona","Barcelona","08036",[426],{"name":427,"role":99,"phone":428,"email":429},"Laura Rosinol, MD","+34-932275428","lrosinol@clinic.cat",{"lat":431,"lon":432},41.38879,2.15899,{"facility":434,"status":107,"city":435,"state":435,"zip":436,"country":399,"geoPoint":437},"Centro Integral Oncologici Clara Campal","Madrid","28050",{"lat":438,"lon":439},40.4165,-3.70256,{"facility":441,"status":8,"city":442,"state":443,"zip":444,"country":399,"contacts":445,"geoPoint":450},"Clinica Universidad de Nevarra","Pamplona","Navarre","31008",[446],{"name":447,"role":99,"phone":448,"email":449},"Paula Rodriguez Otero, MD","+34-948296397","paurodriguez@unav.es",{"lat":451,"lon":452},42.81687,-1.64323,[454],{"name":455,"role":99,"phone":456,"email":457},"Ichnos Sciences Clinical Trials Administrator","(315) 583-1249","clinicaltrials@ichnossciences.com",[],[460,464],{"pmid":461,"type":462,"citation":463},"42206665","DERIVED","Chandralayam Ayyappa Menon V, Matsuura T, Holkova B, Gudi GS, Drake A, Pihlgren M, van der Graaf PH, Gn S, Garton A, Perro M, Konto C, Pacaud L. Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients. Clin Pharmacol Ther. 2026 Aug;120(2):452-464. doi: 10.1002\u002Fcpt.70319. Epub 2026 May 28.",{"pmid":465,"type":462,"citation":466},"39261676","Carretero-Iglesia L, Hall OJ, Berret J, Pais D, Estoppey C, Chimen M, Monney T, Loyau J, Dreyfus C, Macoin J, Perez C, Menon V, Gruber I, Laurendon A, Caro LN, Gudi GS, Matsuura T, van der Graaf PH, Blein S, Mbow ML, Croasdale-Wood R, Srivastava A, Dyson MR, Matthes T, Kaya Z, Edwards CM, Edwards JR, Maiga S, Pellat-Deceunynck C, Touzeau C, Moreau P, Konto C, Drake A, Zhukovsky EA, Perro M, Pihlgren M. ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells. Nat Cancer. 2024 Oct;5(10):1494-1514. doi: 10.1038\u002Fs43018-024-00821-1. Epub 2024 Sep 11.",[],{"nct_id":4,"conditions":469,"biomarkers":471},[470],"Multiple Myeloma",[],{"nct_id":4,"found":473,"summary":474,"prompt_version":484},true,{"design":475,"status":476,"heading":477,"summary":478,"follow_up":479,"word_count":480,"commitments":481,"compensation":482,"drugs_mentioned":483},"This is a Phase 1, open-label study, meaning both you and your doctors will know you are receiving ISB 2001. It will enroll about 200 participants.","completed","Study of ISB 2001 for Relapsed\u002FRefractory Multiple Myeloma","This study is testing a drug called ISB 2001 for people with multiple myeloma that has come back or hasn't responded to other treatments (relapsed\u002Frefractory multiple myeloma). The main goals are to see how safe ISB 2001 is and what side effects it might cause. Researchers will also look at how well ISB 2001 works against multiple myeloma. You might be able to join if you are 18 or older, have multiple myeloma with measurable M-protein, and have good overall health, including blood, liver, kidney, and heart function. The study is looking to enroll about 200 participants.","Your safety will be monitored for up to 18 months after starting treatment.",97,"Participants will receive injections of ISB 2001 until their disease gets worse, side effects become too severe, or they withdraw from the study.","Not stated in the trial record.",[21],"v2"]