[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439778":3},{"organization":4,"outcomesModule":7,"designInfo":113,"detailedDescription":119,"studyPopulation":28,"armGroups":120,"interventions":151,"overallOfficials":159,"centralContacts":163,"locations":170,"responsibleParty":1209,"collaborators":28,"id":1211,"slug":1212,"hasResults":1213,"nctId":1214,"briefTitle":1215,"officialTitle":1216,"acronym":1217,"eligibilityCriteria":1218,"healthyVolunteers":1213,"sex":1219,"minAge":1220,"maxAge":28,"enrollmentInfo":1221,"targetDuration":28,"studyType":1224,"phases":1225,"briefSummary":1228,"conditions":1229,"keywords":28,"overallStatus":173,"whyStopped":28,"lastUpdateSubmitDate":1239,"lastUpdatePostDateStruct":1240,"startDateStruct":1243,"completionDateStruct":1245,"leadSponsor":1247,"locationsCount":1248},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":28},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Phase 1: Number of Participants with Adverse Events (AEs)","Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) including results from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicities (DLTs); as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.","From the first dose of tacabrutideg until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks)",{"measure":14,"description":15,"timeFrame":16},"Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Tacabrutideg","MTD is defined as the highest evaluated dose with an estimated toxicity rate closest to the target, while MAD is the highest dose given if MTD is not reached.","Approximately 28 days",{"measure":18,"description":19,"timeFrame":20},"Phase 1: Recommended dose(s) for Expansion (RDFE) of tacabrutideg","RDFE of tacabrutideg alone will be determined based upon the MTD or MAD.","Approximately 3 years",{"measure":22,"description":23,"timeFrame":24},"Phase 2: Overall response rate (ORR)","Defined as the percentage of participants achieving a best overall response of partial response (PR) or better, assessed by the Independent Review Committee for participants with R\u002FR CLL\u002FSLL and R\u002FR WM (in participants with WM, this is also referred to as major response rate) and by the investigator for other cohorts (R\u002FR MCL, R\u002FR MZL, R\u002FR FL, R\u002FR non-GCB DLBCL, R\u002FR Richter's transformation to DLBCL), evaluated using the Lugano criteria for NHL and SLL, International Workshop of Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL, and the 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM-11) criteria for WM.","approximately 3 years",[26,30,32,34,36,38,40,42,44,47,50,53,56,60,63,67,70,73,76,79,82,85,88,91,94,97,100,103,106,110],{"measure":27,"description":28,"timeFrame":29},"Single dose and steady-state maximum observed plasma concentration (Cmax) of tacabrutideg",null,"Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.",{"measure":31,"description":28,"timeFrame":29},"Single dose and steady-state minimum observed plasma concentration (Cmin) of tacabrutideg",{"measure":33,"description":28,"timeFrame":29},"Single dose and steady-state time to reach Cmax (tmax) of tacabrutideg",{"measure":35,"description":28,"timeFrame":29},"Single dose and steady-state elimination half-life (T1\u002F2) of tacabrutideg",{"measure":37,"description":28,"timeFrame":29},"Single dose and steady-state area under the plasma concentration-time curve (AUC) of tacabrutideg",{"measure":39,"description":28,"timeFrame":29},"Single dose and steady-state apparent total clearance of drug from plasma after oral administration (CL\u002FF) of tacabrutideg",{"measure":41,"description":28,"timeFrame":29},"Single dose and steady-state apparent volume of distribution (Vz\u002FF) of tacabrutideg",{"measure":43,"description":28,"timeFrame":29},"Single dose and steady-state accumulation ratios of tacabrutideg",{"measure":45,"description":28,"timeFrame":46},"Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after tacabrutideg monotherapy","Week 1 Day 1 pre-dose; 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose and 8 hours post-dose; Week 9 Day 1 pre-dose.",{"measure":48,"description":49,"timeFrame":24},"Phase 1: Overall response rate (ORR)","Defined as the percentage of participants whose best overall response is partial response or better, as assessed by the investigator and evaluated according to the following criteria: the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for R\u002FR CLL, the International Workshop on Waldenström's Macroglobulinemia (IWWM-11) criteria for R\u002FR WM (in participants with WM, this is also referred to as major response rate), and the Lugano criteria for R\u002FR NHL.",{"measure":51,"description":52,"timeFrame":24},"Phase 1: Response Rate in Participants with R\u002FR CLL\u002FSLL","Defined as the percentage of participants with R\u002FR CLL\u002FSLL whose best overall response is better than stable disease, as determined by investigators.",{"measure":54,"description":55,"timeFrame":24},"Phase 1: Overall Response Rate in Participants with R\u002FR WM","Defined as the percentage of participants with R\u002FR WM who have a response rate of minor response or better.",{"measure":57,"description":58,"timeFrame":59},"Phase 1: Number of Participants with AEs in part 1e (Japan-only cohort)","Number of Japanese participants in Part 1e with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, that meet protocol-defined DLTs, graded according to the NCI-CTCAE v5.0.","From the first dose of tacabrutideg in Part 1e until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)",{"measure":61,"description":62,"timeFrame":24},"Phase 2: Recommended Phase 2 Dose (RP2D)","The Recommended Phase 2 Dose (RP2D) is determined by the sponsor based on the Safety Monitoring Committee's recommendations, taking into account the overall clinical safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data.",{"measure":64,"description":65,"timeFrame":66},"Phase 2: Number of Participants with AEs","Number of participants with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, graded according to the NCI-CTCAE v5.0.","From the first dose of tacabrutideg in Phase 2 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)",{"measure":68,"description":69,"timeFrame":24},"Phase 2: ORR in Participants with CLL\u002FSLL assessed by investigators","Defined as the percentage of participants with CLL\u002FSLL with a best overall response of PR or better, as determined by investigators.",{"measure":71,"description":72,"timeFrame":24},"Phase 2: Major Response Rate for Participants with WM assessed by investigator","Defined as the percentage of participants with WM whose best overall response is PR or better, as determined by investigators using the IWWM-11 criteria.",{"measure":74,"description":75,"timeFrame":24},"Phase 2: Overall Response Rate for Participants with WM assessed by investigator and IRC","Defined as the percentage of participants who achieve at least a minor response (MR) or a more favorable outcome, as assessed by investigators for participants with R\u002FR WM.",{"measure":77,"description":78,"timeFrame":24},"Phase 2: Rate of Very Good Partial Response (VGPR) or Better in Participants with WM Assessed by Investigator and IRC","Defined as the percentage of participants with R\u002FR WM with best response of VGPR or better as determined by IRC and investigator.",{"measure":80,"description":81,"timeFrame":24},"Phase 2: Response Rate in Participants with R\u002FR CLL\u002FSLL Assessed by Investigator and IRC","Defined as the percentage of participants with R\u002FR CLL\u002FSLL whose best overall response is better than stable disease, as determined by IRC and investigator.",{"measure":83,"description":84,"timeFrame":24},"Phase 2: Duration of Response (DOR)","DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is documented or death, whichever comes first as assessed by the investigator and the IRC.",{"measure":86,"description":87,"timeFrame":24},"Phase 2: Time to Overall Response (TTOR)","TTOR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by IRC and the investigator",{"measure":89,"description":90,"timeFrame":24},"Phase 2: Time to Major Response (TTMR) in Participants with WM","Defined as the time from the date of treatment initiation to the date of first response of PR or better in participants with R\u002FR WM.",{"measure":92,"description":93,"timeFrame":24},"Phase 2: Time to Response in Participants with R\u002FR CLL\u002FSLL Assessed by Investigator and IRC","Defined as the time to first response based on best overall response of better than stable disease, per IRC and investigator.",{"measure":95,"description":96,"timeFrame":24},"Phase 2: Time to Response in Participants with WM Assessed by Investigator and IRC","Defined as the time to first response based on best overall response of minor response or better, per IRC and investigator.",{"measure":98,"description":99,"timeFrame":24},"Phase 2: Time to Next Treatment (TTNT)","Defined as the time from the treatment start date to the initiation of subsequent anticancer therapy.",{"measure":101,"description":102,"timeFrame":24},"Phase 2: Progression- Free Survival (PFS)","PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by IRC for R\u002FR CLL\u002FSLL and R\u002FR WM and by the investigator for all participants.",{"measure":104,"description":105,"timeFrame":24},"Phase 2: Overall Survival (OS)","OS is defined as the time from first study drug administration to the date of death due to any cause",{"measure":107,"description":108,"timeFrame":109},"Phase 2: Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire","Mean change from baseline in the 'physical well-being' and 'functional well-being' subscales of the FACT-Leu for participants with R\u002FR CLL\u002FSLL. FACT-Leu is a 44-item PRO questionnaire with five subscales used to measure health-related quality of life (HRQoL) in leukemia patients.","Baseline and day 1 of Weeks 5, 13, 25, and 37",{"measure":111,"description":112,"timeFrame":109},"Phase 2: National Comprehensive Cancer Network\u002FFunctional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 (NFLymSI-18)","Mean change from baseline in the NFlymSI-18 subscales of disease-related symptoms (DRSP) and 'treatment side effects' for participants with R\u002FR MCL and participants with R\u002FR WM. The NFlymSI-18 is an 18-item patient-reported outcome (PRO) tool specifically designed to assess symptoms and treatment impacts in patients with non-Hodgkin lymphoma.",{"allocation":114,"interventionModel":115,"interventionModelDescription":28,"primaryPurpose":116,"observationalModel":28,"timePerspective":28,"maskingInfo":117},"RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":118,"maskingDescription":28,"whoMasked":28},"NONE","Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.",[121,127,131,135,139,143,147],{"label":122,"type":123,"description":124,"interventionNames":125},"Part 1a (Monotherapy Dose Escalation)","EXPERIMENTAL","Dose escalation in specific subtypes of non-Hodgkin lymphoma (NHL), including relapsed or refractory (R\u002FR) marginal zone lymphoma (MZL), R\u002FR follicular lymphoma (FL) Grades 1, 2, and 3a, R\u002FR mantle cell lymphoma (MCL), R\u002FR chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL), R\u002FR diffuse large B-cell lymphoma (DLBCL), R\u002FR Richter's transformation (RT), and R\u002FR Waldenström macroglobulinemia (WM), to evaluate the safety and tolerability of tacabrutideg.",[126],"Drug: Tacabrutideg",{"label":128,"type":123,"description":129,"interventionNames":130},"Part 1b (Monotherapy Safety Expansion)","Participants with R\u002FR MZL, MCL, CLL\u002FSLL, and WM will be enrolled at selected doses to help determine the recommended dose(s) for expansion (RDFE(s)) for tacabrutideg.",[126],{"label":132,"type":123,"description":133,"interventionNames":134},"Part 1c (Additional Monotherapy Safety Expansion)","Additional safety data will be collected from participants with R\u002FR MZL, WM, RT, DLBCL, or FL to confirm the RDFE(s) of tacabrutideg for those with non-CLL\u002FSLL\u002FMCL histologies.",[126],{"label":136,"type":123,"description":137,"interventionNames":138},"Part 1d (Additional Monotherapy Safety Expansion in R\u002FR CLL\u002FSLL)","Participants with R\u002FR CLL\u002FSLL will be enrolled at selected RDFE(s) to generate additional safety and efficacy data for tacabrutideg.",[126],{"label":140,"type":123,"description":141,"interventionNames":142},"Part 1e (Japan-only Cohort)","Japanese participants with R\u002FR MZL, FL, MCL, CLL\u002FSLL, and WM will be enrolled at selected RDFE(s) to assess the safety and tolerability of tacabrutideg.",[126],{"label":144,"type":123,"description":145,"interventionNames":146},"Part 1f (Additional Monotherapy Safety Expansion in BTKi Naive B-Cell Malignancies)","Participants with CLL\u002FSLL, MCL, WM, MZL, or Richter's transformation to DLBCL who have not received a prior BTKi (either covalent or noncovalent) will be enrolled at selected dose levels.",[126],{"label":148,"type":123,"description":149,"interventionNames":150},"Phase 2 (Monotherapy Expansion)","Cohorts of participants with R\u002FR CLL\u002FSLL, R\u002FR MCL, R\u002FR WM, R\u002FR MZL, R\u002FR FL, R\u002FR RT, and R\u002FR DLBCL will be enrolled to receive the RDFE(s) identified in Phase 1 to further evaluate the safety and efficacy of tacabrutideg.",[126],[152],{"type":153,"name":154,"description":155,"armGroupLabels":156,"otherNames":157},"DRUG","Tacabrutideg","Orally administered",[122,128,132,136,140,144,148],[158],"BGB-16673",[160],{"name":161,"affiliation":5,"role":162},"Study Director","STUDY_DIRECTOR",[164,168],{"name":5,"role":165,"phone":166,"phoneExt":28,"email":167},"CONTACT","1.877.828.5568","clinicaltrials@beonemed.com",{"name":169,"role":165,"phone":28,"phoneExt":28,"email":28},"Study Director, MD",[171,185,196,205,214,224,233,242,252,262,271,280,290,299,309,319,330,340,350,360,370,380,390,400,408,414,420,430,439,449,459,469,481,490,500,510,519,528,534,544,553,564,573,582,591,597,603,609,621,630,640,650,660,672,682,692,702,712,722,732,743,747,756,765,774,783,792,801,810,820,831,840,849,858,867,876,885,896,905,911,917,926,935,947,956,965,970,979,990,996,1005,1010,1014,1018,1027,1031,1042,1051,1057,1063,1069,1078,1087,1098,1107,1117,1126,1135,1144,1155,1164,1173,1182,1191,1200],{"facility":172,"status":173,"city":174,"state":175,"zip":176,"country":177,"countryCode":178,"cosmosGeoPoint":179,"geoPoint":184,"contacts":28},"University of Alabama At Birmingham Hospital","RECRUITING","Birmingham","Alabama","35294-0004","United States","US",{"type":180,"coordinates":181},"Point",[182,183],-86.80249,33.52066,{"lat":183,"lon":182},{"facility":186,"status":187,"city":188,"state":189,"zip":190,"country":177,"countryCode":178,"cosmosGeoPoint":191,"geoPoint":195,"contacts":28},"Mayo Clinic Phoenix","COMPLETED","Phoenix","Arizona","85054-4502",{"type":180,"coordinates":192},[193,194],-112.07404,33.44838,{"lat":194,"lon":193},{"facility":197,"status":173,"city":198,"state":189,"zip":199,"country":177,"countryCode":178,"cosmosGeoPoint":200,"geoPoint":204,"contacts":28},"Honor Health Research Institute","Scottsdale","85258-4566",{"type":180,"coordinates":201},[202,203],-111.89903,33.50921,{"lat":203,"lon":202},{"facility":206,"status":173,"city":207,"state":189,"zip":208,"country":177,"countryCode":178,"cosmosGeoPoint":209,"geoPoint":213,"contacts":28},"University of Arizona Cancer Center","Tucson","85724-0001",{"type":180,"coordinates":210},[211,212],-110.92648,32.22174,{"lat":212,"lon":211},{"facility":215,"status":173,"city":216,"state":217,"zip":218,"country":177,"countryCode":178,"cosmosGeoPoint":219,"geoPoint":223,"contacts":28},"University of California San Diego (Ucsd) Moores Cancer Center","La Jolla","California","92093-1503",{"type":180,"coordinates":220},[221,222],-117.2742,32.84727,{"lat":222,"lon":221},{"facility":225,"status":173,"city":226,"state":217,"zip":227,"country":177,"countryCode":178,"cosmosGeoPoint":228,"geoPoint":232,"contacts":28},"Stanford Medicine","Palo Alto","94304-2205",{"type":180,"coordinates":229},[230,231],-122.14302,37.44188,{"lat":231,"lon":230},{"facility":234,"status":173,"city":235,"state":217,"zip":236,"country":177,"countryCode":178,"cosmosGeoPoint":237,"geoPoint":241,"contacts":28},"UCLA Santa Monica Cancer Care","Santa Monica","90404-2023",{"type":180,"coordinates":238},[239,240],-118.49138,34.01949,{"lat":240,"lon":239},{"facility":243,"status":173,"city":244,"state":245,"zip":246,"country":177,"countryCode":178,"cosmosGeoPoint":247,"geoPoint":251,"contacts":28},"Uchealth North","Fort Collins","Colorado","80528-3413",{"type":180,"coordinates":248},[249,250],-105.08442,40.58526,{"lat":250,"lon":249},{"facility":253,"status":173,"city":254,"state":255,"zip":256,"country":177,"countryCode":178,"cosmosGeoPoint":257,"geoPoint":261,"contacts":28},"Mayo Clinic Jacksonville","Jacksonville","Florida","32224-1865",{"type":180,"coordinates":258},[259,260],-81.65565,30.33218,{"lat":260,"lon":259},{"facility":263,"status":173,"city":264,"state":255,"zip":265,"country":177,"countryCode":178,"cosmosGeoPoint":266,"geoPoint":270,"contacts":28},"Mount Sinai Medical Center Braman Comprehensive Cancer Center","Miami","33140",{"type":180,"coordinates":267},[268,269],-80.19366,25.77427,{"lat":269,"lon":268},{"facility":272,"status":173,"city":273,"state":255,"zip":274,"country":177,"countryCode":178,"cosmosGeoPoint":275,"geoPoint":279,"contacts":28},"Tampa General Hospital Cancer Institute","Tampa","33606-3571",{"type":180,"coordinates":276},[277,278],-82.45843,27.94752,{"lat":278,"lon":277},{"facility":281,"status":173,"city":282,"state":283,"zip":284,"country":177,"countryCode":178,"cosmosGeoPoint":285,"geoPoint":289,"contacts":28},"Augusta University","Augusta","Georgia","30912-0002",{"type":180,"coordinates":286},[287,288],-81.97484,33.47097,{"lat":288,"lon":287},{"facility":291,"status":173,"city":292,"state":283,"zip":293,"country":177,"countryCode":178,"cosmosGeoPoint":294,"geoPoint":298,"contacts":28},"Southeastern Regional Medical Center","Newnan","30265-8001",{"type":180,"coordinates":295},[296,297],-84.79966,33.38067,{"lat":297,"lon":296},{"facility":300,"status":187,"city":301,"state":302,"zip":303,"country":177,"countryCode":178,"cosmosGeoPoint":304,"geoPoint":308,"contacts":28},"Midwestern Regional Medical Center","Zion","Illinois","60099-2676",{"type":180,"coordinates":305},[306,307],-87.83285,42.44613,{"lat":307,"lon":306},{"facility":310,"status":173,"city":311,"state":312,"zip":313,"country":177,"countryCode":178,"cosmosGeoPoint":314,"geoPoint":318,"contacts":28},"University of Iowa Hospitals and Clinics","Iowa City","Iowa","52242-1009",{"type":180,"coordinates":315},[316,317],-91.53017,41.66113,{"lat":317,"lon":316},{"facility":320,"status":321,"city":322,"state":323,"zip":324,"country":177,"countryCode":178,"cosmosGeoPoint":325,"geoPoint":329,"contacts":28},"Norton Cancer Institute Pavilion","ACTIVE_NOT_RECRUITING","Louisville","Kentucky","40207-4700",{"type":180,"coordinates":326},[327,328],-85.75941,38.25424,{"lat":328,"lon":327},{"facility":331,"status":173,"city":332,"state":333,"zip":334,"country":177,"countryCode":178,"cosmosGeoPoint":335,"geoPoint":339,"contacts":28},"Mary Bird Perkins Cancer Center","Baton Rouge","Louisiana","70809-3738",{"type":180,"coordinates":336},[337,338],-91.18747,30.44332,{"lat":338,"lon":337},{"facility":341,"status":173,"city":342,"state":343,"zip":344,"country":177,"countryCode":178,"cosmosGeoPoint":345,"geoPoint":349,"contacts":28},"American Oncology Partners of Maryland Pa","Bethesda","Maryland","20817-7847",{"type":180,"coordinates":346},[347,348],-77.10026,38.98067,{"lat":348,"lon":347},{"facility":351,"status":173,"city":352,"state":353,"zip":354,"country":177,"countryCode":178,"cosmosGeoPoint":355,"geoPoint":359,"contacts":28},"Dana Farber Cancer Institute","Boston","Massachusetts","02215-5418",{"type":180,"coordinates":356},[357,358],-71.05977,42.35843,{"lat":358,"lon":357},{"facility":361,"status":173,"city":362,"state":363,"zip":364,"country":177,"countryCode":178,"cosmosGeoPoint":365,"geoPoint":369,"contacts":28},"Karmanos Cancer Institute","Detroit","Michigan","48201-2013",{"type":180,"coordinates":366},[367,368],-83.04575,42.33143,{"lat":368,"lon":367},{"facility":371,"status":173,"city":372,"state":373,"zip":374,"country":177,"countryCode":178,"cosmosGeoPoint":375,"geoPoint":379,"contacts":28},"Mayo Clinic Rochester","Rochester","Minnesota","55905-0001",{"type":180,"coordinates":376},[377,378],-92.4699,44.02163,{"lat":378,"lon":377},{"facility":381,"status":173,"city":382,"state":383,"zip":384,"country":177,"countryCode":178,"cosmosGeoPoint":385,"geoPoint":389,"contacts":28},"Comprehensive Cancer Centers of Nevada","Las Vegas","Nevada","89169-3321",{"type":180,"coordinates":386},[387,388],-115.13722,36.17497,{"lat":388,"lon":387},{"facility":391,"status":173,"city":392,"state":393,"zip":394,"country":177,"countryCode":178,"cosmosGeoPoint":395,"geoPoint":399,"contacts":28},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14203",{"type":180,"coordinates":396},[397,398],-78.87837,42.88645,{"lat":398,"lon":397},{"facility":401,"status":173,"city":393,"state":393,"zip":402,"country":177,"countryCode":178,"cosmosGeoPoint":403,"geoPoint":407,"contacts":28},"Columbia University Medical Center","10032",{"type":180,"coordinates":404},[405,406],-74.00597,40.71427,{"lat":406,"lon":405},{"facility":409,"status":173,"city":393,"state":393,"zip":410,"country":177,"countryCode":178,"cosmosGeoPoint":411,"geoPoint":413,"contacts":28},"Weill Cornell Medical College Newyork Presbyterian Hospital","10065-4870",{"type":180,"coordinates":412},[405,406],{"lat":406,"lon":405},{"facility":415,"status":173,"city":393,"state":393,"zip":416,"country":177,"countryCode":178,"cosmosGeoPoint":417,"geoPoint":419,"contacts":28},"Memorial Sloan Kettering Cancer Center Mskcc","10065-6800",{"type":180,"coordinates":418},[405,406],{"lat":406,"lon":405},{"facility":421,"status":173,"city":422,"state":423,"zip":424,"country":177,"countryCode":178,"cosmosGeoPoint":425,"geoPoint":429,"contacts":28},"Tennesse Oncology Chattanooga Downtown","Chattanooga","Tennessee","37404",{"type":180,"coordinates":426},[427,428],-85.30968,35.04563,{"lat":428,"lon":427},{"facility":431,"status":173,"city":432,"state":423,"zip":433,"country":177,"countryCode":178,"cosmosGeoPoint":434,"geoPoint":438,"contacts":28},"Tennessee Oncology, Pllc 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University","Kayseri","38030",{"type":180,"coordinates":1122},[1123,1124],35.48528,38.73222,{"lat":1124,"lon":1123},{"facility":1127,"status":173,"city":1128,"state":28,"zip":1129,"country":1111,"countryCode":28,"cosmosGeoPoint":1130,"geoPoint":1134,"contacts":28},"Sakarya Training and Research Hospital","Sakarya","54100",{"type":180,"coordinates":1131},[1132,1133],32.07583,39.50333,{"lat":1133,"lon":1132},{"facility":1136,"status":173,"city":1137,"state":28,"zip":1138,"country":1111,"countryCode":28,"cosmosGeoPoint":1139,"geoPoint":1143,"contacts":28},"Ondokuz Mayis University","Samsun","55200",{"type":180,"coordinates":1140},[1141,1142],36.3361,41.27976,{"lat":1142,"lon":1141},{"facility":1145,"status":173,"city":1146,"state":28,"zip":1147,"country":1148,"countryCode":1149,"cosmosGeoPoint":1150,"geoPoint":1154,"contacts":28},"Edinburgh Cancer Centre","Edinburgh","EH4 2XU","United Kingdom","UK",{"type":180,"coordinates":1151},[1152,1153],-3.19648,55.95206,{"lat":1153,"lon":1152},{"facility":1156,"status":173,"city":1157,"state":28,"zip":1158,"country":1148,"countryCode":1149,"cosmosGeoPoint":1159,"geoPoint":1163,"contacts":28},"St Jamess University Hospital","Leeds","LS9 7TF",{"type":180,"coordinates":1160},[1161,1162],-1.54785,53.79648,{"lat":1162,"lon":1161},{"facility":1165,"status":173,"city":1166,"state":28,"zip":1167,"country":1148,"countryCode":1149,"cosmosGeoPoint":1168,"geoPoint":1172,"contacts":28},"Freeman Hospital","Newcastle upon Tyne","NE7 7DN",{"type":180,"coordinates":1169},[1170,1171],-1.61396,54.97328,{"lat":1171,"lon":1170},{"facility":1174,"status":173,"city":1175,"state":28,"zip":1176,"country":1148,"countryCode":1149,"cosmosGeoPoint":1177,"geoPoint":1181,"contacts":28},"Genesiscare Cambridge","Newmarket","CB8 7XN",{"type":180,"coordinates":1178},[1179,1180],0.40418,52.24467,{"lat":1180,"lon":1179},{"facility":1183,"status":173,"city":1184,"state":28,"zip":1185,"country":1148,"countryCode":1149,"cosmosGeoPoint":1186,"geoPoint":1190,"contacts":28},"Norfolk and Norwich University Hospitals Nhs Foundation Trust","Norwich","NR4 7UY",{"type":180,"coordinates":1187},[1188,1189],1.29834,52.62783,{"lat":1189,"lon":1188},{"facility":1192,"status":173,"city":1193,"state":28,"zip":1194,"country":1148,"countryCode":1149,"cosmosGeoPoint":1195,"geoPoint":1199,"contacts":28},"Nottingham University Hospitals Nhs Trust","Nottingham","NG5 1PB",{"type":180,"coordinates":1196},[1197,1198],-1.15047,52.9536,{"lat":1198,"lon":1197},{"facility":1201,"status":173,"city":1202,"state":28,"zip":1203,"country":1148,"countryCode":1149,"cosmosGeoPoint":1204,"geoPoint":1208,"contacts":28},"Derriford Hospital","Plymouth","PL6 8DH",{"type":180,"coordinates":1205},[1206,1207],-4.14305,50.37153,{"lat":1207,"lon":1206},{"type":1210,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778",false,"NCT05006716","A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":1222,"type":1223},645,"ESTIMATED","INTERVENTIONAL",[1226,1227],"PHASE1","PHASE2","Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[1230,1231,1232,1233,1234,1235,1236,1237,1238],"B-cell Malignancy","Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma","2026-08-20",{"date":1241,"type":1242},"2026-08-21","ACTUAL",{"date":1244,"type":1242},"2021-09-13",{"date":1246,"type":1223},"2029-11",{"name":5,"class":6},115]