[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06590961":3,"trial-entities:NCT06590961":180,"trial-summary:NCT06590961":191},{"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":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":44,"sex":57,"minimum_age":58,"maximum_age":15,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":88,"locations":91,"central_contacts":171,"overall_officials":177,"references":178,"see_also_links":179},"NCT06590961","UBX-303-101","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","RECRUITING","2027-08","2025-08","2025-11-19","2025-02-20","Ubix Therapeutics, Inc.","INDUSTRY",null,"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.",[18],"Relapsed\u002FRefractory B-cell Malignancies",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE1",{"count":25,"type":26},94,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","UBX-303061","UBX-303061 oral dosage",[30],[34,38,41],{"measure":35,"description":36,"timeFrame":37},"Number of subjects with Protocol Specified Dose-Limiting Toxicities","Phase 1a and 1b","28-days",{"measure":39,"description":36,"timeFrame":40},"To establish the maximum tolerated dose and\u002For recommended Phase 1b dose(s)","Up to End of Treatment (up to 9 months)",{"measure":42,"description":43,"timeFrame":40},"Number of subjects with dose interruptions, reductions, and doses administered","Phase 1a and qb",[45,47,49,51,53,55],{"measure":46,"description":36,"timeFrame":40},"To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response",{"measure":48,"description":36,"timeFrame":40},"To assess genetic markers including but not limited to BTK, PLCG2, MYD88",{"measure":50,"description":36,"timeFrame":37},"To assess Cmin",{"measure":52,"description":36,"timeFrame":37},"To assess tmax",{"measure":54,"description":36,"timeFrame":37},"To assess AUC",{"measure":56,"description":36,"timeFrame":37},"To assess Cmax","ALL","18 Years",false,{"inclusion":61,"exclusion":69,"raw_text":87},[62,63,64,65,66,67,68],"Capable of giving signed informed consent","Age ≥18 years","ECOG performance status ≤2.","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.","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","All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria","Adequate organ and bone marrow function",[70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86],"For subjects with lymphoma:","Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.","Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.","Unconjugated monoclonal antibody therapies \\\u003C6 weeks before the first dose of study treatment.","Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.","Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.","Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.","History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.","Any immunotherapy within 4 weeks of first dose of study drug.","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).","Previously exposed to BTK degradation therapy","Malignant disease, other than that being treated in this study.","Radiotherapy within 2 weeks of the first dose of study treatment","Known hypersensitivity to BTK degraders or any of the ingredients.","Impaired cardiac function or clinically significant cardiac disease","Subjects with history of severe bleeding disorders and known\u002Fsuspected other autoimmune disease","Major surgery within 4 weeks of the first dose of study treatment","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",[89,90],"ADULT","OLDER_ADULT",[92,101,109,117,127,135,143,151,159,163,167],{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":97,"geoPoint":98},"University of Michigan","Ann Arbor","Michigan","48109","United States",{"lat":99,"lon":100},42.27756,-83.74088,{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":97,"geoPoint":106},"Gabrail Cancer Center","Canton","Oklahoma","44718",{"lat":107,"lon":108},36.05365,-98.58842,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":97,"geoPoint":114},"MD Anderson Cancer Center","Houston","Texas","77030",{"lat":115,"lon":116},29.76328,-95.36327,{"facility":118,"status":119,"city":120,"state":121,"zip":122,"country":123,"geoPoint":124},"MICS Centrum Medyczne Toruń","NOT_YET_RECRUITING","Torun","Kuyavian-Pomeranian Voivodeship","87-100","Poland",{"lat":125,"lon":126},53.01375,18.59814,{"facility":128,"status":119,"city":129,"state":130,"zip":131,"country":123,"geoPoint":132},"Pratia, MTZ Clinical Research","Warsaw","Mazowieckie Voivodeship","02-172",{"lat":133,"lon":134},52.22977,21.01178,{"facility":136,"status":119,"city":137,"state":138,"zip":139,"country":123,"geoPoint":140},"Pratia, Oncology Katowice","Katowice","Silesian Voivodeship","40-519",{"lat":141,"lon":142},50.2597,19.02173,{"facility":144,"status":119,"city":145,"state":146,"zip":147,"country":123,"geoPoint":148},"AidPort","Grodzisk Wielkopolski","Wielkopolskie Voivodeship","62-065",{"lat":149,"lon":150},52.22762,16.36534,{"facility":152,"status":8,"city":153,"state":153,"zip":154,"country":155,"geoPoint":156},"Asan Medical Center","Seoul","05505","South Korea",{"lat":157,"lon":158},37.566,126.9784,{"facility":160,"status":8,"city":153,"state":153,"zip":161,"country":155,"geoPoint":162},"Samsung Medical Center","06351",{"lat":157,"lon":158},{"facility":164,"status":8,"city":153,"state":153,"zip":165,"country":155,"geoPoint":166},"The Catholic University of Korea, Seoul St. Mary's Hospital","06591",{"lat":157,"lon":158},{"facility":168,"status":8,"city":153,"state":153,"zip":169,"country":155,"geoPoint":170},"The Catholic University of Korea, Yeouido St. Mary's Hospital","07345",{"lat":157,"lon":158},[172],{"name":173,"role":174,"phone":175,"email":176},"Project Manager","CONTACT","+82 (2) 6334 2475","ubix_co@ubixtrx.com",[],[],[],{"nct_id":4,"conditions":181,"biomarkers":190},[182,183,184,185,186,187,188,189],"B-Cell Malignant Neoplasm","Chronic Lymphocytic Leukemia","Diffuse Large B-Cell Lymphoma","Follicular Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Small Lymphocytic Lymphoma","Waldenstrom Macroglobulinemia",[],{"nct_id":4,"found":192,"summary":193,"prompt_version":202},true,{"design":194,"status":195,"heading":196,"summary":197,"follow_up":198,"word_count":199,"commitments":198,"compensation":200,"drugs_mentioned":201},"This is an open-label (meaning both you and your doctor will know what treatment you are receiving) study, designed to evaluate the safety and anti-cancer activity of UBX-303061. It is a Phase 1a\u002F1b study, meaning it's an early-stage trial.","completed","UBX-303061 for Relapsed\u002FRefractory B-Cell Malignancies","This study is testing a new oral medication called UBX-303061 for people with B-cell malignancies (cancers of certain white blood cells) that have returned or not responded to previous treatments. This is the first time UBX-303061 is being tested in humans. The main goals are to find a safe dose and see how well it works against the cancer. You might be able to join if you are at least 18 years old, have a B-cell malignancy like CLL\u002FSLL or DLBCL, and have already tried at least two other treatments. The study is currently recruiting about 94 participants.","The study will measure side effects and how well you tolerate the medication for up to 9 months.",98,"Not stated in the trial record.",[30],"v2"]