[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561499":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":19,"locations":25,"responsibleParty":131,"collaborators":18,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":18,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":18,"enrollmentInfo":142,"targetDuration":18,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":18,"overallStatus":28,"whyStopped":18,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Ubix Therapeutics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"UBX-303061","EXPERIMENTAL",[12],"Drug: UBX-303061",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DRUG","UBX-303061 oral dosage",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Project Manager","CONTACT","+82 (2) 6334 2475","ubix_co@ubixtrx.com",[26,40,50,60,73,83,93,103,113,119,125],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":18},"University of Michigan","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-83.74088,42.27756,{"lat":38,"lon":37},{"facility":41,"status":28,"city":42,"state":43,"zip":44,"country":32,"countryCode":33,"cosmosGeoPoint":45,"geoPoint":49,"contacts":18},"Gabrail Cancer Center","Canton","Oklahoma","44718",{"type":35,"coordinates":46},[47,48],-98.58842,36.05365,{"lat":48,"lon":47},{"facility":51,"status":28,"city":52,"state":53,"zip":54,"country":32,"countryCode":33,"cosmosGeoPoint":55,"geoPoint":59,"contacts":18},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":35,"coordinates":56},[57,58],-95.36327,29.76328,{"lat":58,"lon":57},{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":18},"MICS Centrum Medyczne Toruń","NOT_YET_RECRUITING","Torun","Kuyavian-Pomeranian Voivodeship","87-100","Poland","PL",{"type":35,"coordinates":69},[70,71],18.59814,53.01375,{"lat":71,"lon":70},{"facility":74,"status":62,"city":75,"state":76,"zip":77,"country":66,"countryCode":67,"cosmosGeoPoint":78,"geoPoint":82,"contacts":18},"Pratia, MTZ Clinical Research","Warsaw","Mazowieckie Voivodeship","02-172",{"type":35,"coordinates":79},[80,81],21.01178,52.22977,{"lat":81,"lon":80},{"facility":84,"status":62,"city":85,"state":86,"zip":87,"country":66,"countryCode":67,"cosmosGeoPoint":88,"geoPoint":92,"contacts":18},"Pratia, Oncology Katowice","Katowice","Silesian Voivodeship","40-519",{"type":35,"coordinates":89},[90,91],19.02173,50.2597,{"lat":91,"lon":90},{"facility":94,"status":62,"city":95,"state":96,"zip":97,"country":66,"countryCode":67,"cosmosGeoPoint":98,"geoPoint":102,"contacts":18},"AidPort","Grodzisk Wielkopolski","Wielkopolskie Voivodeship","62-065",{"type":35,"coordinates":99},[100,101],16.36534,52.22762,{"lat":101,"lon":100},{"facility":104,"status":28,"city":105,"state":105,"zip":106,"country":107,"countryCode":18,"cosmosGeoPoint":108,"geoPoint":112,"contacts":18},"Asan Medical Center","Seoul","05505","South Korea",{"type":35,"coordinates":109},[110,111],126.9784,37.566,{"lat":111,"lon":110},{"facility":114,"status":28,"city":105,"state":105,"zip":115,"country":107,"countryCode":18,"cosmosGeoPoint":116,"geoPoint":118,"contacts":18},"Samsung Medical Center","06351",{"type":35,"coordinates":117},[110,111],{"lat":111,"lon":110},{"facility":120,"status":28,"city":105,"state":105,"zip":121,"country":107,"countryCode":18,"cosmosGeoPoint":122,"geoPoint":124,"contacts":18},"The Catholic University of Korea, Seoul St. Mary's Hospital","06591",{"type":35,"coordinates":123},[110,111],{"lat":111,"lon":110},{"facility":126,"status":28,"city":105,"state":105,"zip":127,"country":107,"countryCode":18,"cosmosGeoPoint":128,"geoPoint":130,"contacts":18},"The Catholic University of Korea, Yeouido St. Mary's Hospital","07345",{"type":35,"coordinates":129},[110,111],{"lat":111,"lon":110},{"type":132,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100561499","phase-1-ubx-303061-in-subjects-with-relapsedrefractory-b-cell-malignancies-100561499",false,"NCT06590961","UBX-303061 in Subjects With Relapsed\u002FRefractory B-Cell Malignancies","A Phase Ia\u002FIb, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed\u002FRefractory B-Cell Malignancies","Key Inclusion Criteria\n\n* Capable of giving signed informed consent\n* Age ≥18 years\n* ECOG performance status ≤2.\n* Phase Ia (dose-escalation part only): Subjects with relapsed and\u002For refractory B-cell malignancies (CLL\u002FSLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.\n* Phase Ib (dose-expansion only): Subjects with relapsed and\u002For refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL\u002FSLL or DLBCL or MCL or FL, WM, MZL\n* All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria\n* Adequate organ and bone marrow function\n\nKey Exclusion Criteria\n\n* For subjects with lymphoma:\n\n  * Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.\n  * Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.\n  * Unconjugated monoclonal antibody therapies \\\u003C6 weeks before the first dose of study treatment.\n  * Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.\n  * Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.\n  * Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.\n  * History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.\n  * Any immunotherapy within 4 weeks of first dose of study drug.\n  * The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is \\\u003C5 times the t1\u002F2 of the previously administered agent(s).\n* Previously exposed to BTK degradation therapy\n* Malignant disease, other than that being treated in this study.\n* Radiotherapy within 2 weeks of the first dose of study treatment\n* Known hypersensitivity to BTK degraders or any of the ingredients.\n* Impaired cardiac function or clinically significant cardiac disease\n* Subjects with history of severe bleeding disorders and known\u002Fsuspected other autoimmune disease\n* Major surgery within 4 weeks of the first dose of study treatment","ALL","18 Years",{"count":143,"type":144},94,"ESTIMATED","INTERVENTIONAL",[147],"PHASE1","This is a first-in-human Phase 1a\u002F1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed\u002Frefractory B-cell malignancies.",[150],"Relapsed\u002FRefractory B-cell Malignancies","2025-11-16",{"date":153,"type":154},"2025-11-19","ACTUAL",{"date":156,"type":154},"2025-02-20",{"date":158,"type":144},"2027-08",{"name":5,"class":6},11]