[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439860":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":52,"studyPopulation":11,"armGroups":53,"interventions":75,"overallOfficials":86,"centralContacts":90,"locations":96,"responsibleParty":334,"collaborators":11,"id":336,"slug":11,"hasResults":337,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":11,"eligibilityCriteria":341,"healthyVolunteers":337,"sex":342,"minAge":343,"maxAge":11,"enrollmentInfo":344,"targetDuration":11,"studyType":347,"phases":348,"briefSummary":350,"conditions":351,"keywords":11,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":362},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":11},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C",null,"Day 1 Through Day 21",{"measure":14,"description":11,"timeFrame":15},"Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0","First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days",{"measure":17,"description":11,"timeFrame":15},"Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0",[19,22,24,26,28,30,34,37,40,43],{"measure":20,"description":11,"timeFrame":21},"Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for Denikitug","Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days",{"measure":23,"description":11,"timeFrame":21},"PK Parameter: Minimum Observed Concentration (Cmin) for Denikitug",{"measure":25,"description":11,"timeFrame":21},"PK Parameter: Time of Maximum Observed Concentration (Tmax) for Denikitug",{"measure":27,"description":11,"timeFrame":21},"PK Parameter: Area Under the Concentration-time Curve (AUC) for Denikitug",{"measure":29,"description":11,"timeFrame":21},"Percentage of Participants who Developed Antidrug Antibody (ADA) Against Denikitug",{"measure":31,"description":32,"timeFrame":33},"Objective response rate (ORR) in Part D","Objective response rate is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1","Day 1 Up to End of Treatment (24 months)",{"measure":35,"description":36,"timeFrame":33},"Disease control rate (DCR)","Disease control rate is defined as the proportion of participants who achieve CR, PR, or stable disease (SD) as assessed by RECIST Version 1.1",{"measure":38,"description":39,"timeFrame":33},"Time to response (TTR)","Time to response is defined as the time from the first dose of Denikitug in combination with Zimberelimab to the first documentation of CR or PR that is subsequently confirmed",{"measure":41,"description":42,"timeFrame":33},"Duration of response (DOR)","Duration of response is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive progressive disease (PD) or death from any cause, if applicable.",{"measure":44,"description":45,"timeFrame":33},"Progression-free survival (PFS)","Progression-free survival is defined as the time from the first dose of Denikitug in combination with Zimberelimab to the earlier of the first documentation of definitive PD or death from any cause",{"allocation":47,"interventionModel":48,"interventionModelDescription":11,"primaryPurpose":49,"observationalModel":11,"timePerspective":11,"maskingInfo":50},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":51,"maskingDescription":11,"whoMasked":11},"NONE","Part D allocation for 1 cohort will be randomized.",[54,59,62,66,69,72],{"label":55,"type":56,"description":11,"interventionNames":57},"Part A - Denikitug Dose Escalation","EXPERIMENTAL",[58],"Drug: Denikitug",{"label":60,"type":56,"description":11,"interventionNames":61},"Part B - Mandatory Paired Tumor Biopsy",[58],{"label":63,"type":56,"description":11,"interventionNames":64},"Part C: Denikitug + Zimberelimab Dose Escalation",[58,65],"Drug: Zimberelimab",{"label":67,"type":56,"description":11,"interventionNames":68},"Part D: Denikitug + Zimberelimab Dose Expansion",[58,65],{"label":70,"type":56,"description":11,"interventionNames":71},"Part E: Denikitug Monotherapy Dose Expansion",[58],{"label":73,"type":56,"description":11,"interventionNames":74},"Part F: Denikitug Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule",[58,65],[76,83],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"DRUG","Denikitug","Administered Intravenously",[55,60,63,67,70,73],[82],"GS-1811",{"type":77,"name":84,"description":79,"armGroupLabels":85,"otherNames":11},"Zimberelimab",[63,67,73],[87],{"name":88,"affiliation":5,"role":89},"Gilead Study Director","STUDY_DIRECTOR",[91],{"name":92,"role":93,"phone":94,"phoneExt":11,"email":95},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[97,111,120,131,141,151,161,167,176,185,195,207,217,226,237,248,256,262,268,277,288,297,306,312,319,325],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":11},"University of California San Diego","RECRUITING","La Jolla","California","92093","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-117.2742,32.84727,{"lat":109,"lon":108},{"facility":112,"status":99,"city":113,"state":101,"zip":114,"country":103,"countryCode":104,"cosmosGeoPoint":115,"geoPoint":119,"contacts":11},"Stanford Cancer Center","Palo Alto","94305",{"type":106,"coordinates":116},[117,118],-122.14302,37.44188,{"lat":118,"lon":117},{"facility":121,"status":122,"city":123,"state":124,"zip":125,"country":103,"countryCode":104,"cosmosGeoPoint":126,"geoPoint":130,"contacts":11},"Smilow Cancer Center","COMPLETED","New Haven","Connecticut","06510",{"type":106,"coordinates":127},[128,129],-72.92816,41.30815,{"lat":129,"lon":128},{"facility":132,"status":99,"city":133,"state":134,"zip":135,"country":103,"countryCode":104,"cosmosGeoPoint":136,"geoPoint":140,"contacts":11},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"type":106,"coordinates":137},[138,139],-71.05977,42.35843,{"lat":139,"lon":138},{"facility":142,"status":99,"city":143,"state":144,"zip":145,"country":103,"countryCode":104,"cosmosGeoPoint":146,"geoPoint":150,"contacts":11},"Tennessee Oncology, PLLC","Nashville","Tennessee","37203",{"type":106,"coordinates":147},[148,149],-86.78444,36.16589,{"lat":149,"lon":148},{"facility":152,"status":99,"city":153,"state":154,"zip":155,"country":103,"countryCode":104,"cosmosGeoPoint":156,"geoPoint":160,"contacts":11},"University of Texas Southwestern Medical Center","Dallas","Texas","39090",{"type":106,"coordinates":157},[158,159],-96.80667,32.78306,{"lat":159,"lon":158},{"facility":162,"status":99,"city":153,"state":154,"zip":163,"country":103,"countryCode":104,"cosmosGeoPoint":164,"geoPoint":166,"contacts":11},"Sarah Cannon Research Institute at Mary Crowley","75230",{"type":106,"coordinates":165},[158,159],{"lat":159,"lon":158},{"facility":168,"status":99,"city":169,"state":154,"zip":170,"country":103,"countryCode":104,"cosmosGeoPoint":171,"geoPoint":175,"contacts":11},"MD Anderson Cancer Center","Houston","77030",{"type":106,"coordinates":172},[173,174],-95.36327,29.76328,{"lat":174,"lon":173},{"facility":177,"status":99,"city":178,"state":154,"zip":179,"country":103,"countryCode":104,"cosmosGeoPoint":180,"geoPoint":184,"contacts":11},"NEXT Oncology","San Antonio","78229",{"type":106,"coordinates":181},[182,183],-98.49363,29.42412,{"lat":183,"lon":182},{"facility":186,"status":99,"city":187,"state":188,"zip":189,"country":103,"countryCode":104,"cosmosGeoPoint":190,"geoPoint":194,"contacts":11},"University of Wisconsin Clinical Sciences Center","Madison","Wisconsin","53705",{"type":106,"coordinates":191},[192,193],-89.40123,43.07305,{"lat":193,"lon":192},{"facility":196,"status":99,"city":197,"state":198,"zip":199,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":11},"Chris O'Brien Lifehouse","Camperdown","New South Wales","2050","Australia","AU",{"type":106,"coordinates":203},[204,205],151.17642,-33.88965,{"lat":205,"lon":204},{"facility":208,"status":99,"city":209,"state":210,"zip":211,"country":200,"countryCode":201,"cosmosGeoPoint":212,"geoPoint":216,"contacts":11},"Monash Medical Centre","Clayton","Victoria","3168",{"type":106,"coordinates":213},[214,215],145.11667,-37.91667,{"lat":215,"lon":214},{"facility":218,"status":99,"city":219,"state":210,"zip":220,"country":200,"countryCode":201,"cosmosGeoPoint":221,"geoPoint":225,"contacts":11},"Peter MacCallum Cancer Centre","Melbourne","3000",{"type":106,"coordinates":222},[223,224],144.96332,-37.814,{"lat":224,"lon":223},{"facility":227,"status":99,"city":228,"state":11,"zip":229,"country":230,"countryCode":231,"cosmosGeoPoint":232,"geoPoint":236,"contacts":11},"University Health Network, Princess Margaret Cancer Centre","Toronto","M5G 2M9","Canada","CA",{"type":106,"coordinates":233},[234,235],-79.39864,43.70643,{"lat":235,"lon":234},{"facility":238,"status":99,"city":239,"state":11,"zip":240,"country":241,"countryCode":242,"cosmosGeoPoint":243,"geoPoint":247,"contacts":11},"Hospital Universitari Vall d´Hebrón","Barcelona","08035","Spain","ES",{"type":106,"coordinates":244},[245,246],2.15899,41.38879,{"lat":246,"lon":245},{"facility":168,"status":99,"city":249,"state":11,"zip":250,"country":241,"countryCode":242,"cosmosGeoPoint":251,"geoPoint":255,"contacts":11},"Madrid","28033",{"type":106,"coordinates":252},[253,254],-3.70256,40.4165,{"lat":254,"lon":253},{"facility":257,"status":99,"city":249,"state":11,"zip":258,"country":241,"countryCode":242,"cosmosGeoPoint":259,"geoPoint":261,"contacts":11},"Hospital Universitario 12 de Octubre","28041",{"type":106,"coordinates":260},[253,254],{"lat":254,"lon":253},{"facility":263,"status":99,"city":249,"state":11,"zip":264,"country":241,"countryCode":242,"cosmosGeoPoint":265,"geoPoint":267,"contacts":11},"Hospital Universitario Quironsalud Madrid","28223",{"type":106,"coordinates":266},[253,254],{"lat":254,"lon":253},{"facility":269,"status":99,"city":270,"state":11,"zip":271,"country":241,"countryCode":242,"cosmosGeoPoint":272,"geoPoint":276,"contacts":11},"Clinica Universidad de Navarra","Pamplona","31008",{"type":106,"coordinates":273},[274,275],-1.64323,42.81687,{"lat":275,"lon":274},{"facility":278,"status":99,"city":279,"state":11,"zip":280,"country":281,"countryCode":282,"cosmosGeoPoint":283,"geoPoint":287,"contacts":11},"Changhua Christian Hospital","Changhua","500","Taiwan","TW",{"type":106,"coordinates":284},[285,286],120.5512,24.0692,{"lat":286,"lon":285},{"facility":289,"status":99,"city":290,"state":11,"zip":291,"country":281,"countryCode":282,"cosmosGeoPoint":292,"geoPoint":296,"contacts":11},"Chi Mei Hospital, Liouying","Tainan","73657",{"type":106,"coordinates":293},[294,295],120.21333,22.99083,{"lat":295,"lon":294},{"facility":298,"status":99,"city":299,"state":11,"zip":300,"country":281,"countryCode":282,"cosmosGeoPoint":301,"geoPoint":305,"contacts":11},"National Taiwan University Cancer Center (NTUCC)","Taipei","100229",{"type":106,"coordinates":302},[303,304],121.52639,25.05306,{"lat":304,"lon":303},{"facility":307,"status":99,"city":299,"state":11,"zip":308,"country":281,"countryCode":282,"cosmosGeoPoint":309,"geoPoint":311,"contacts":11},"National Taiwan University Hospital","100",{"type":106,"coordinates":310},[303,304],{"lat":304,"lon":303},{"facility":313,"status":314,"city":299,"state":11,"zip":315,"country":281,"countryCode":282,"cosmosGeoPoint":316,"geoPoint":318,"contacts":11},"Taipei Tzu Chi General Hospital","WITHDRAWN","110",{"type":106,"coordinates":317},[303,304],{"lat":304,"lon":303},{"facility":320,"status":99,"city":299,"state":11,"zip":321,"country":281,"countryCode":282,"cosmosGeoPoint":322,"geoPoint":324,"contacts":11},"Taipei Veterans General Hospital","11217",{"type":106,"coordinates":323},[303,304],{"lat":304,"lon":303},{"facility":326,"status":99,"city":327,"state":11,"zip":328,"country":281,"countryCode":282,"cosmosGeoPoint":329,"geoPoint":333,"contacts":11},"Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital","Taoyuan City","33308",{"type":106,"coordinates":330},[331,332],121.29696,24.99368,{"lat":332,"lon":331},{"type":335,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100439860",false,"NCT05007782","Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Denikitug (GS-1811), an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Disease:\n\n  * Part A: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.\n  * Part B: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.\n  * Part C: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or whose disease is indicated for anti- programmed cell death protein 1 or programmed cell death ligand 1 (PD-\\[L\\]1) monoclonal antibody monotherapy.\n  * Part D: Individuals with pathologically confirmed select advanced solid tumors.\n  * Part E: Individuals with pathologically confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatment known to confer clinical benefit.\n  * Part F: Individuals with pathologically-confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatments known to confer clinical benefit; or, for participants who will undergo combination therapy, have disease which is indicated for anti-PD-(L)1 mAb monotherapy.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 for individuals in Parts A, B, and C, and 0 or 1 for individuals in Parts D, E, and F.\n* Adequate organ function.\n* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.\n* Tissue requirement:\n\n  * Parts A, C, D, E and F: Must provide pre-treatment adequate tumor tissue sample prior to enrollment.\n  * Part B and select participants in Parts C and F: Must have fresh pre-treatment and on-treatment biopsies for biomarker analysis.\n\nKey Exclusion Criteria:\n\n* Concurrent anticancer treatment.\n* Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: immunotherapy or biologic therapy (\\\u003C 28 days), chemotherapy (\\\u003C 21 days), targeted small molecule therapy (\\\u003C 14 days), hormonal therapy or other adjunctive therapy (\\\u003C 14 days) or radiotherapy (\\\u003C 21 days).\n* Any prior CCR8 directed therapy.\n* Prior allogeneic tissue\u002Fsolid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.\n* Concurrent active malignancy other than nonmelanoma skin cancer, curatively resected carcinoma in situ, localized prostate cancer, or superficial bladder cancer after undergoing potentially curative therapy with no evidence of disease. Individuals with other previous malignancies are eligible if disease-free for \\> 2 years.\n* History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.\n* History of autoimmune disease or active autoimmune disease requiring systemic treatment within 2 years.\n* History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).\n* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires IV antibiotics.\n* Active hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV), and\u002For human immunodeficiency virus (HIV).\n* Positive serum pregnancy test or breastfeeding female.\n* Live vaccines within 30 days prior to first dose.\n* Significant cardiovascular disease.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":345,"type":346},416,"ESTIMATED","INTERVENTIONAL",[349],"PHASE1","This is a first-in-human (FIH) study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and\u002For the recommended Phase 2 dose (RP2D) of denikitug (also known as GS-1811) as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.\n\nThis study will be conducted in 6 parts (Parts A, B, and E: monotherapy, Parts C and D: combination therapy, and Part F for both monotherapy and combination therapy) in participants with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or in participants with select solid tumors.",[352],"Advanced Solid Tumor","2025-12-26",{"date":355,"type":356},"2025-12-29","ACTUAL",{"date":358,"type":356},"2021-08-18",{"date":360,"type":346},"2028-12",{"name":5,"class":6},26]