[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100377763":3},{"organization":4,"armGroups":7,"interventions":80,"overallOfficials":128,"centralContacts":132,"locations":138,"responsibleParty":594,"collaborators":596,"id":599,"slug":600,"hasResults":601,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":86,"eligibilityCriteria":605,"healthyVolunteers":601,"sex":606,"minAge":607,"maxAge":86,"enrollmentInfo":608,"targetDuration":86,"studyType":611,"phases":612,"briefSummary":615,"conditions":616,"keywords":625,"overallStatus":141,"whyStopped":86,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":665},{"fullName":5,"class":6},"Inhibrx Biosciences, Inc","INDUSTRY",[8,14,19,23,27,32,36,41,45,49,53,59,64,71,75],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 INBRX-106 Escalation (Not Recruiting)","EXPERIMENTAL","INBRX-106 will be escalated in subjects with locally advanced or metastatic solid tumors.",[13],"Drug: INBRX-106 - Hexavalent OX40 agonist antibody",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting)","INBRX-106 will be escalated, in combination with pembrolizumab, in subjects with locally advanced or metastatic solid tumors.",[13,18],"Drug: pembrolizumab 200 mg",{"label":20,"type":10,"description":21,"interventionNames":22},"Part 2 (Cohorts C1\u002FC2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting)","Subjects with melanoma (any type), head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma or MSI\u002FTMB-high tumors that are relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106",[13,18],{"label":24,"type":10,"description":25,"interventionNames":26},"Part 2 (Cohort C3) INBRX-106 Escalation in NSCLC (Not Recruiting)","Subjects with non-small cell carcinoma relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106",[18],{"label":28,"type":10,"description":29,"interventionNames":30},"Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)","Subjects with non-small cell lung cancer will be treated with alternating dosing of INBRX-106 0.3 mg\u002Fkg Q6W and 400 mg pembrolizumab IV Q6W. This is one of the randomized cohorts.",[13,31],"Drug: pembrolizumab 400 mg",{"label":33,"type":10,"description":34,"interventionNames":35},"Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)","Subjects with non-small cell lung cancer will be given a 0.3 mg\u002Fkg priming dose of INBRX-106 in cycle 1, followed by 0.1 mg\u002Fkg INBRX-106 and 200 mg pembrolizumab IV every 3 weeks in subsequent cycles. This is one of the randomized cohorts.",[13,18,31],{"label":37,"type":38,"description":39,"interventionNames":40},"Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting)","ACTIVE_COMPARATOR","Subjects with non-small cell lung cancer will be treated with 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts.",[13],{"label":42,"type":10,"description":43,"interventionNames":44},"Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not-Recruiting)","Subjects with non-small cell lung cancer will be treated concurrently every 6 weeks with INBRX-106 0.1 mg\u002Fkg and 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts.",[13],{"label":46,"type":10,"description":47,"interventionNames":48},"Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab (Not Recruiting)","Subjects with melanoma (any type), head and neck squamous cell carcinoma (non-nasopharyngeal) OR nasopharyngeal carcinoma, MSI-high, TMB-high or MMR-deficient tumors, will be treated with INBRX-106 in combination with 200mg pembrolizumab IV every 3 weeks.",[13,18],{"label":50,"type":10,"description":51,"interventionNames":52},"Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI\u002FTMB-high\u002FMMRd tumors Not Recuriting","Subjects with solid tumors that have confirmed MSI-high, TMB-high or MMR-deficient states who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks",[13,18],{"label":54,"type":10,"description":55,"interventionNames":56},"Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting)","Subjects with ocular (uveal) melanoma who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks",[13,18,57,58],"Drug: Carboplatin AUC-5","Drug: Pemetrexed 500 mg\u002Fm2",{"label":60,"type":10,"description":61,"interventionNames":62},"Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC","This Arm is no longer recruiting. Subjects with advanced\u002Fmetastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg\u002Fkg, 200mg pembrolizumab, 500mg\u002Fm2 pemetrexed and carboplatin AUC-5 IV every 3 weeks",[13,18,58,63],"Drug: Cisplatin 75mg\u002Fm2",{"label":65,"type":10,"description":66,"interventionNames":67},"Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC","This Arm is no longer recruiting. Subjects with advanced\u002Fmetastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg\u002Fkg, 200mg pembrolizumab, 500mg\u002Fm2 pemetrexed and 75mg\u002Fm2 cisplatin IV every 3 weeks",[13,18,68,69,70],"Drug: Carboplatin AUC-6","Drug: Paclitaxel 200mg\u002Fm2","Drug: Nab paclitaxel 100mg\u002Fm2",{"label":72,"type":10,"description":73,"interventionNames":74},"Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC","This Arm is no longer recruiting. Subjects with advanced\u002Fmetastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg\u002Fkg, 200mg pembrolizumab, 200mg\u002Fm2 paclitaxel and carboplatin AUC-6 IV every 3 weeks OR INBRX-106, 200mg pembrolizumab, 100mg\u002Fm2 nab-paclitaxel (dosed Days 1,8 and 15 every cycle) and carboplatin AUC-6 IV every 3 weeks. Treating physician to determine if paclitaxel or nab-paclitaxel will be given",[13,18],{"label":76,"type":10,"description":77,"interventionNames":78},"Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC","Subjects with resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC , any PD-L1 TPS will receive neoadjuvant treatment with INBRX-106 0.1 mg\u002Fkg, 200 mg pembrolizumab, cisplatin 75 mg\u002Fm2 (dosed Day 1 only) with gemcitabine 1000 mg\u002Fm2 (dosed on Days 1 and 8) for patients with squamous cell NSCLC given every 3 weeks OR neoadjuvant treatment with INBRX-106 0.1 mg\u002Fkg, 200 mg pembrolizumab, cisplatin 75 mg\u002Fm2 with pemetrexed 500 mg\u002Fm2 for patients with non-squamous cell NSCLC given every 3 weeks. Carboplatin AUC5 (dosed on Day 1 only) can be substituted for Cisplatin following Cycle 1 at the Investigator's discretion and per protocol and due to cisplatin-related toxicity. Neoadjuvant treatment will be given for up to 4 cycles followed by surgery (lobectomy, bilobectomy or pneumonectomy). After surgery, all patients will receive adjuvant treatment consisting of INBRX-106 0.1 mg\u002Fkg, 200 mg pembrolizumab given every 3 weeks for up to 13 cycles.",[13,18,57,58,63,79],"Drug: Gemcitabine (1000 mg\u002Fm2)",[81,87,93,98,102,106,112,116,120,124],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"DRUG","INBRX-106 - Hexavalent OX40 agonist antibody","The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).",[9,20,15,28,33,37,42,46,50,54,60,65,72,76],null,{"type":82,"name":88,"description":89,"armGroupLabels":90,"otherNames":91},"pembrolizumab 200 mg","pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.",[24,20,15,33,46,50,54,60,65,72,76],[92],"KEYTRUDA",{"type":82,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"pembrolizumab 400 mg","pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks)",[28,33],[92],{"type":82,"name":99,"description":100,"armGroupLabels":101,"otherNames":86},"Carboplatin AUC-5","carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4. Cohort F8, carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycle 2-4.",[54,76],{"type":82,"name":103,"description":104,"armGroupLabels":105,"otherNames":86},"Carboplatin AUC-6","carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4",[65],{"type":82,"name":107,"description":108,"armGroupLabels":109,"otherNames":110},"Pemetrexed 500 mg\u002Fm2","pemetrexed 500 mg\u002Fm2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles. In Cohort F8, pemetrexed 500 mg\u002Fm2 by IV infusion given on Day 1 of each 21-Day cycle of cycles 1-4.",[54,60,76],[111],"Alimta®",{"type":82,"name":113,"description":114,"armGroupLabels":115,"otherNames":86},"Cisplatin 75mg\u002Fm2","cisplatin 75mg\u002Fm2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4",[60,76],{"type":82,"name":117,"description":118,"armGroupLabels":119,"otherNames":86},"Paclitaxel 200mg\u002Fm2","paclitaxel 200mg\u002Fm2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4",[65],{"type":82,"name":121,"description":122,"armGroupLabels":123,"otherNames":86},"Nab paclitaxel 100mg\u002Fm2","Nab paclitaxel 100mg\u002Fm2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4",[65],{"type":82,"name":125,"description":126,"armGroupLabels":127,"otherNames":86},"Gemcitabine (1000 mg\u002Fm2)","Gemcitabine 1000 mg\u002Fm2 given by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle of cycles 1-4",[76],[129],{"name":130,"affiliation":5,"role":131},"Clinical Lead","STUDY_DIRECTOR",[133],{"name":134,"role":135,"phone":136,"phoneExt":86,"email":137},"Study Director - Inhibrx Biosciences, Inc","CONTACT","858-500-7833","clinicaltrials@inhibrx.com",[139,161,176,191,203,216,233,249,262,279,290,300,318,329,342,351,361,370,380,397,407,417,427,437,447,456,465,474,489,499,509,518,523,528,537,545,550,555,565,573,578,586],{"facility":140,"status":141,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":152,"contacts":153},"City of Hope","RECRUITING","Duarte","California","91010","United States","US",{"type":148,"coordinates":149},"Point",[150,151],-117.97729,34.13945,{"lat":151,"lon":150},[154,158],{"name":155,"role":135,"phone":156,"phoneExt":86,"email":157},"New Patient Services","800-826-4673","shhussain@coh.org",{"name":159,"role":160,"phone":86,"phoneExt":86,"email":86},"Aditya Shreenivas, MD","PRINCIPAL_INVESTIGATOR",{"facility":162,"status":141,"city":163,"state":143,"zip":164,"country":145,"countryCode":146,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Los Angeles Cancer Network","Glendale","91204",{"type":148,"coordinates":166},[167,168],-118.25508,34.14251,{"lat":168,"lon":167},[171,174],{"name":172,"role":135,"phone":86,"phoneExt":86,"email":173},"Elizabeth Brown","Elizabeth.Brown@lahomg.com",{"name":175,"role":160,"phone":86,"phoneExt":86,"email":86},"Sungwon Kyung, MD",{"facility":177,"status":141,"city":178,"state":143,"zip":179,"country":145,"countryCode":146,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"California Research Institute","Los Angeles","90027",{"type":148,"coordinates":181},[182,183],-118.24368,34.05223,{"lat":183,"lon":182},[186,189],{"name":187,"role":135,"phone":86,"phoneExt":86,"email":188},"Swati Shrestha","sw@caresinst.com",{"name":190,"role":160,"phone":86,"phoneExt":86,"email":86},"Ghassan Al-Jazayrly, MD",{"facility":192,"status":141,"city":178,"state":143,"zip":193,"country":145,"countryCode":146,"cosmosGeoPoint":194,"geoPoint":196,"contacts":197},"Valkyrie Clinical Trials","90069",{"type":148,"coordinates":195},[182,183],{"lat":183,"lon":182},[198,201],{"name":199,"role":135,"phone":86,"phoneExt":86,"email":200},"Myo Zaw","myo.zaw@valkyrieclinicaltrials.com",{"name":202,"role":160,"phone":86,"phoneExt":86,"email":86},"David Berz, MD",{"facility":192,"status":141,"city":204,"state":143,"zip":205,"country":145,"countryCode":146,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Murrieta","92562",{"type":148,"coordinates":207},[208,209],-117.21392,33.55391,{"lat":209,"lon":208},[212,215],{"name":213,"role":135,"phone":86,"phoneExt":86,"email":214},"Isabella Gudino","Isabella.gudino@vctcare.com",{"name":202,"role":160,"phone":86,"phoneExt":86,"email":86},{"facility":217,"status":141,"city":218,"state":143,"zip":219,"country":145,"countryCode":146,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Providence Medical Foundation","Santa Rosa","95403",{"type":148,"coordinates":221},[222,223],-122.71443,38.44047,{"lat":223,"lon":222},[226,231],{"name":227,"role":135,"phone":228,"phoneExt":229,"email":230},"Clinical Research Coordinator","707-521-3810","1181","jackson.barnard@providence.org",{"name":232,"role":160,"phone":86,"phoneExt":86,"email":86},"Ian Anderson, MD",{"facility":234,"status":141,"city":235,"state":236,"zip":237,"country":145,"countryCode":146,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Clermont Oncology Center","Clermont","Florida","34711",{"type":148,"coordinates":239},[240,241],-81.77285,28.54944,{"lat":241,"lon":240},[244,247],{"name":245,"role":135,"phone":86,"phoneExt":86,"email":246},"Kiran Penta","kiran@aorcorp.com",{"name":248,"role":160,"phone":86,"phoneExt":86,"email":86},"Gopal Kunta, MD",{"facility":250,"status":141,"city":251,"state":236,"zip":252,"country":145,"countryCode":146,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Mid Florida Hematology and Oncology Center","Orange City","32763",{"type":148,"coordinates":254},[255,256],-81.29867,28.94888,{"lat":256,"lon":255},[259,260],{"name":245,"role":135,"phone":86,"phoneExt":86,"email":246},{"name":261,"role":160,"phone":86,"phoneExt":86,"email":86},"Santosh Nair, MD",{"facility":263,"status":141,"city":264,"state":265,"zip":266,"country":145,"countryCode":146,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Winship Cancer Institute - Emory University","Atlanta","Georgia","30322",{"type":148,"coordinates":268},[269,270],-84.38798,33.749,{"lat":270,"lon":269},[273,277],{"name":274,"role":135,"phone":275,"phoneExt":86,"email":276},"Kimberly Homere","404-778-6583","kimberly.homere@emory.edu",{"name":278,"role":160,"phone":86,"phoneExt":86,"email":86},"Conor Steuer, MD",{"facility":280,"status":281,"city":282,"state":283,"zip":284,"country":145,"countryCode":146,"cosmosGeoPoint":285,"geoPoint":289,"contacts":86},"The University of Chicago Medical Center","ACTIVE_NOT_RECRUITING","Chicago","Illinois","60637",{"type":148,"coordinates":286},[287,288],-87.65005,41.85003,{"lat":288,"lon":287},{"facility":291,"status":281,"city":292,"state":293,"zip":294,"country":145,"countryCode":146,"cosmosGeoPoint":295,"geoPoint":299,"contacts":86},"University of Iowa","Iowa City","Iowa","52242",{"type":148,"coordinates":296},[297,298],-91.53017,41.66113,{"lat":298,"lon":297},{"facility":301,"status":141,"city":302,"state":303,"zip":304,"country":145,"countryCode":146,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"Norton Cancer Institute","Louisville","Kentucky","40202",{"type":148,"coordinates":306},[307,308],-85.75941,38.25424,{"lat":308,"lon":307},[311,316],{"name":312,"role":135,"phone":313,"phoneExt":314,"email":315},"Jenn Broadway, RN","502-629-2500","19535","Jennifer.Broadway@nortonhealthcare.org",{"name":317,"role":160,"phone":86,"phoneExt":86,"email":86},"John Hamm, MD",{"facility":319,"status":320,"city":321,"state":322,"zip":323,"country":145,"countryCode":146,"cosmosGeoPoint":324,"geoPoint":328,"contacts":86},"Barbara Ann Karmanos Cancer Institute","COMPLETED","Detroit","Michigan","48201",{"type":148,"coordinates":325},[326,327],-83.04575,42.33143,{"lat":327,"lon":326},{"facility":330,"status":141,"city":321,"state":322,"zip":331,"country":145,"countryCode":146,"cosmosGeoPoint":332,"geoPoint":334,"contacts":335},"Henry Ford Cancer Institute","48202",{"type":148,"coordinates":333},[326,327],{"lat":327,"lon":326},[336,340],{"name":337,"role":135,"phone":338,"phoneExt":86,"email":339},"Mahmoud Hossami","313-725-7842","mhossam1@hfhs.org",{"name":341,"role":160,"phone":86,"phoneExt":86,"email":86},"Amy Weise, MD",{"facility":343,"status":281,"city":344,"state":322,"zip":345,"country":145,"countryCode":146,"cosmosGeoPoint":346,"geoPoint":350,"contacts":86},"START Midwest","Grand Rapids","49546",{"type":148,"coordinates":347},[348,349],-85.66809,42.96336,{"lat":349,"lon":348},{"facility":352,"status":281,"city":353,"state":354,"zip":355,"country":145,"countryCode":146,"cosmosGeoPoint":356,"geoPoint":360,"contacts":86},"HealthPartners Cancer Research Center","Saint Louis Park","Minnesota","55426",{"type":148,"coordinates":357},[358,359],-93.34801,44.9483,{"lat":359,"lon":358},{"facility":362,"status":320,"city":363,"state":354,"zip":364,"country":145,"countryCode":146,"cosmosGeoPoint":365,"geoPoint":369,"contacts":86},"HealthPartners Cancer Research Center (Regions Hospital)","Saint Paul","55101",{"type":148,"coordinates":366},[367,368],-93.09327,44.94441,{"lat":368,"lon":367},{"facility":371,"status":320,"city":372,"state":373,"zip":374,"country":145,"countryCode":146,"cosmosGeoPoint":375,"geoPoint":379,"contacts":86},"Intermountain Health Cancer Centers of Montana","Billings","Montana","59102",{"type":148,"coordinates":376},[377,378],-108.50069,45.78329,{"lat":378,"lon":377},{"facility":381,"status":141,"city":382,"state":383,"zip":384,"country":145,"countryCode":146,"cosmosGeoPoint":385,"geoPoint":389,"contacts":390},"Nebraska Cancer Specialists","Omaha","Nebraska","68130",{"type":148,"coordinates":386},[387,388],-95.94043,41.25626,{"lat":388,"lon":387},[391,395],{"name":392,"role":135,"phone":393,"phoneExt":86,"email":394},"Lindsey Becker","402-691-5255","lbecker@nebraskacancer.com",{"name":396,"role":160,"phone":86,"phoneExt":86,"email":86},"Ralph Hauke, MD",{"facility":398,"status":281,"city":399,"state":400,"zip":401,"country":145,"countryCode":146,"cosmosGeoPoint":402,"geoPoint":406,"contacts":86},"Montefiore Medical Center","The Bronx","New York","10467",{"type":148,"coordinates":403},[404,405],-73.86641,40.84985,{"lat":405,"lon":404},{"facility":408,"status":281,"city":409,"state":410,"zip":411,"country":145,"countryCode":146,"cosmosGeoPoint":412,"geoPoint":416,"contacts":86},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":148,"coordinates":413},[414,415],-81.69541,41.4995,{"lat":415,"lon":414},{"facility":418,"status":281,"city":419,"state":420,"zip":421,"country":145,"countryCode":146,"cosmosGeoPoint":422,"geoPoint":426,"contacts":86},"Providence Portland Medical Center","Portland","Oregon","97213",{"type":148,"coordinates":423},[424,425],-122.67621,45.52345,{"lat":425,"lon":424},{"facility":428,"status":281,"city":429,"state":430,"zip":431,"country":145,"countryCode":146,"cosmosGeoPoint":432,"geoPoint":436,"contacts":86},"Vanderbilt University School of Medicine","Nashville","Tennessee","37204",{"type":148,"coordinates":433},[434,435],-86.78444,36.16589,{"lat":435,"lon":434},{"facility":438,"status":320,"city":439,"state":440,"zip":441,"country":145,"countryCode":146,"cosmosGeoPoint":442,"geoPoint":446,"contacts":86},"Sarah Cannon Research Institute at Mary Crowley","Dallas","Texas","75230",{"type":148,"coordinates":443},[444,445],-96.80667,32.78306,{"lat":445,"lon":444},{"facility":448,"status":320,"city":449,"state":440,"zip":450,"country":145,"countryCode":146,"cosmosGeoPoint":451,"geoPoint":455,"contacts":86},"Renovatio Clinical - El Paso","El Paso","79915",{"type":148,"coordinates":452},[453,454],-106.48693,31.75872,{"lat":454,"lon":453},{"facility":457,"status":320,"city":458,"state":440,"zip":459,"country":145,"countryCode":146,"cosmosGeoPoint":460,"geoPoint":464,"contacts":86},"NEXT Oncology","San Antonio","78229",{"type":148,"coordinates":461},[462,463],-98.49363,29.42412,{"lat":463,"lon":462},{"facility":466,"status":320,"city":467,"state":440,"zip":468,"country":145,"countryCode":146,"cosmosGeoPoint":469,"geoPoint":473,"contacts":86},"Renovatio Clinical","The Woodlands","77380",{"type":148,"coordinates":470},[471,472],-95.48938,30.15799,{"lat":472,"lon":471},{"facility":475,"status":141,"city":476,"state":440,"zip":477,"country":145,"countryCode":146,"cosmosGeoPoint":478,"geoPoint":482,"contacts":483},"The University of Texas Health Science Center at Tyler","Tyler","75701",{"type":148,"coordinates":479},[480,481],-95.30106,32.35126,{"lat":481,"lon":480},[484,487],{"name":485,"role":135,"phone":86,"phoneExt":86,"email":486},"Chaney Story","Chaney.Story@uttyler.edu",{"name":488,"role":160,"phone":86,"phoneExt":86,"email":86},"Erminia Massarelli, MD, PhD, MS",{"facility":490,"status":320,"city":491,"state":492,"zip":493,"country":145,"countryCode":146,"cosmosGeoPoint":494,"geoPoint":498,"contacts":86},"Virginia Cancer Specialists","Fairfax","Virginia","22031",{"type":148,"coordinates":495},[496,497],-77.30637,38.84622,{"lat":497,"lon":496},{"facility":500,"status":281,"city":501,"state":502,"zip":503,"country":145,"countryCode":146,"cosmosGeoPoint":504,"geoPoint":508,"contacts":86},"Froedtert Hospital and the Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":148,"coordinates":505},[506,507],-87.90647,43.0389,{"lat":507,"lon":506},{"facility":510,"status":320,"city":511,"state":86,"zip":86,"country":511,"countryCode":512,"cosmosGeoPoint":513,"geoPoint":517,"contacts":86},"Curie Oncology","Singapore","SG",{"type":148,"coordinates":514},[515,516],103.85007,1.28967,{"lat":516,"lon":515},{"facility":519,"status":320,"city":511,"state":86,"zip":86,"country":511,"countryCode":512,"cosmosGeoPoint":520,"geoPoint":522,"contacts":86},"Icon Cancer Centre Farrer Park",{"type":148,"coordinates":521},[515,516],{"lat":516,"lon":515},{"facility":524,"status":320,"city":511,"state":86,"zip":86,"country":511,"countryCode":512,"cosmosGeoPoint":525,"geoPoint":527,"contacts":86},"Icon Cancer Centre Mount Alvernia",{"type":148,"coordinates":526},[515,516],{"lat":516,"lon":515},{"facility":529,"status":281,"city":530,"state":86,"zip":86,"country":531,"countryCode":86,"cosmosGeoPoint":532,"geoPoint":536,"contacts":86},"The Catholic University of Korea, St. Vincent's Hospital","Gyeonggi-do","South Korea",{"type":148,"coordinates":533},[534,535],126.76917,37.58944,{"lat":535,"lon":534},{"facility":538,"status":281,"city":539,"state":86,"zip":86,"country":531,"countryCode":86,"cosmosGeoPoint":540,"geoPoint":544,"contacts":86},"Asan Medical Center","Seoul",{"type":148,"coordinates":541},[542,543],126.9784,37.566,{"lat":543,"lon":542},{"facility":546,"status":281,"city":539,"state":86,"zip":86,"country":531,"countryCode":86,"cosmosGeoPoint":547,"geoPoint":549,"contacts":86},"Severance Hospital, Yonsei University Health System",{"type":148,"coordinates":548},[542,543],{"lat":543,"lon":542},{"facility":551,"status":281,"city":539,"state":86,"zip":86,"country":531,"countryCode":86,"cosmosGeoPoint":552,"geoPoint":554,"contacts":86},"The Catholic University of Korea Seoul St. Mary's Hospital,",{"type":148,"coordinates":553},[542,543],{"lat":543,"lon":542},{"facility":556,"status":281,"city":557,"state":86,"zip":86,"country":558,"countryCode":559,"cosmosGeoPoint":560,"geoPoint":564,"contacts":86},"Changhua Christian Hospital (CCH)","Changhua","Taiwan","TW",{"type":148,"coordinates":561},[562,563],120.5512,24.0692,{"lat":563,"lon":562},{"facility":566,"status":281,"city":567,"state":86,"zip":86,"country":558,"countryCode":559,"cosmosGeoPoint":568,"geoPoint":572,"contacts":86},"E-Da Cancer Hospital","Kaohsiung City",{"type":148,"coordinates":569},[570,571],120.31333,22.61626,{"lat":571,"lon":570},{"facility":574,"status":281,"city":567,"state":86,"zip":86,"country":558,"countryCode":559,"cosmosGeoPoint":575,"geoPoint":577,"contacts":86},"Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)",{"type":148,"coordinates":576},[570,571],{"lat":571,"lon":570},{"facility":579,"status":281,"city":580,"state":86,"zip":86,"country":558,"countryCode":559,"cosmosGeoPoint":581,"geoPoint":585,"contacts":86},"National Cheng Kung University Hospital","Tainan",{"type":148,"coordinates":582},[583,584],120.21333,22.99083,{"lat":584,"lon":583},{"facility":587,"status":320,"city":588,"state":86,"zip":86,"country":558,"countryCode":559,"cosmosGeoPoint":589,"geoPoint":593,"contacts":86},"Taipei Veterans General Hospital","Taipei",{"type":148,"coordinates":590},[591,592],121.52639,25.05306,{"lat":592,"lon":591},{"type":595,"investigatorFullName":86,"investigatorTitle":86,"investigatorAffiliation":86,"oldNameTitle":86,"oldOrganization":86},"SPONSOR",[597],{"name":598,"class":6},"Merck Sharp & Dohme LLC","100377763","phase-1-study-of-inbrx-106-and-inbrx-106-in-combination-with-pembrolizumab-keytruda-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-hexavalent-ox40-agonist-100377763",false,"NCT04198766","Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)","An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1\u002F2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors","Select Inclusion Criteria:\n\n* Males or females aged ≥18 years.\n* Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.\n* Part 2 (single-agent expansion cohort): Subjects with NSCLC, melanoma, HNSCC, G\u002FGEA, RCC, or TCC, with histologically confirmed, locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies including CPI or for whom no standard or clinically acceptable therapy exists.\n* Part 4 (expansion cohorts in combination with pembrolizumab, with or without chemotherapy): Subjects with melanoma (all types), HNSCC, G\u002FGEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metastatic, non resectable disease, which is either CPI-naive (melanoma, HNSCC, NPC) or progressed despite all standard therapies including CPI (NSCLC, RCC, TCC, uveal melanoma, MSI-high, TMB-high, or MMR-deficient solid tumors) or for whom no standard or clinically acceptable therapy exists.\n* For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1\u002FL1 regimen.\n* For Cohort F4 (HNSCC and NPC), subjects may be previously treated with no more than 1 prior chemotherapy regimen in metastatic setting. Prior PD-1\u002FL1 in curative (neo-adjuvant\u002Fadjuvant) setting is allowed only if completed \\>\u002F= 6 months prior to progression to local recurrence or metastatic disease.\n* For Cohort F8, subjects must have previously untreated, histologically confirmed Stage II, IIIA or IIIB (T3-4N2) NSCLC. Lymph node disease requires histologic confirmation, while T3 disease requires only radiographic documentation. Subjects need to be able to undergo planned surgery.\n* All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.\n* PD-L1 by IHC (22C3): Parts 1 and 3: IHC optional. Part 2: IHC result mandatory but any score allowed. Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). For Cohort F8, any TPS (including 0%) is acceptable.\n* Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.\n\nSelect Exclusion Criteria:\n\n* Prior exposure to OX40 agonists. Exposure to anti-PD-1 and\u002For anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways.\n* Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions.\n* Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)\n* Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-106.\n* Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.\n* Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.\n* Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply.\n* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply.\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.\n* Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease \\\u003C 3 months prior to enrollment on this trial; left ventricular ejection fraction (LVEF) \\\u003C 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension; or oxygen saturation \\\u003C92% on room air.\n* Active, hemodynamically significant pulmonary embolism within 12 weeks prior to enrollment on this trial.\n* Major surgery within 4 weeks prior to enrollment on this trial.\n* Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.\n* Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.\n* Additional in- and exclusion criteria per protocol.","ALL","18 Years",{"count":609,"type":610},340,"ESTIMATED","INTERVENTIONAL",[613,614],"PHASE1","PHASE2","This is a Phase 1\u002F2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \\& Dohme LLC, a subsidiary of Merck \\& Co., Inc., Rahway, NJ, USA.",[617,618,619,620,621,622,623,624],"Solid Tumor","Non-Small Cell Lung Cancer","Head and Neck Cancer","Melanoma","Gastric Cancer","Renal Cell Carcinoma","Urothelial Carcinoma","Resectable Non-Small-Cell Lung Cancer",[626,627,628,619,629,618,630,631,632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,655],"Phase 1 and Phase 2","Phase 1 and Phase 2 Clinical Trial","Solid Tumors","Lung Cancer","OX40 receptor agonist","PD-L1 positive","Pembrolizumab","Keytruda","Chemotherapy","Immunotherapy","HNSCC","Oropharyngeal cancer","Hypopharyngeal cancer","Oral cancer","INBRX-106","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type","Neoplasms","Neoplasms, Squamous Cell","Head and Neck Neoplasms","Neoplasms by Site","Carcinoma","Carcinoma, Squamous Cell","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents, Immunological","Antineoplastic Agents","Squamous Cell Carcinoma of Head and Neck","NSCLC","Neoadjuvant","Adjuvant","2026-07-28",{"date":658,"type":659},"2026-07-29","ACTUAL",{"date":661,"type":659},"2019-12-10",{"date":663,"type":610},"2033-07",{"name":5,"class":6},42]