[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588428":3},{"organization":4,"outcomesModule":7,"designInfo":84,"detailedDescription":90,"studyPopulation":83,"armGroups":91,"interventions":98,"overallOfficials":107,"centralContacts":111,"locations":117,"responsibleParty":958,"collaborators":960,"id":963,"slug":964,"hasResults":965,"nctId":966,"briefTitle":967,"officialTitle":968,"acronym":83,"eligibilityCriteria":969,"healthyVolunteers":965,"sex":970,"minAge":971,"maxAge":972,"enrollmentInfo":973,"targetDuration":83,"studyType":976,"phases":977,"briefSummary":980,"conditions":981,"keywords":83,"overallStatus":120,"whyStopped":83,"lastUpdateSubmitDate":983,"lastUpdatePostDateStruct":984,"startDateStruct":987,"completionDateStruct":989,"leadSponsor":991,"locationsCount":992},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":45,"otherOutcomes":83},[9,13,17,20,24,26,28,31,33,35,38,40,42],{"measure":10,"description":11,"timeFrame":12},"Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)","A DLT is any of a prespecified list of adverse events (AEs) that occur during Cycle 1 (up to 21 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 21 days.","Cycle 1 (up to approximately 21 days); each cycle is 21 days",{"measure":14,"description":15,"timeFrame":16},"Part 1: Percentage of Participants Who Experience an Adverse Event (AE)","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.","Up to approximately 5 years",{"measure":18,"description":19,"timeFrame":16},"Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.",{"measure":21,"description":22,"timeFrame":23},"Part 1: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma","Blood samples will be collected at specified intervals for the determination of AUC.","At designated timepoints (up to approximately 5 years)",{"measure":25,"description":22,"timeFrame":23},"Part 1: AUC of anti-HER3 antibody-conjugated DXd (anti-HER3-ac-DXd) in plasma",{"measure":27,"description":22,"timeFrame":23},"Part 1: AUC of DXd in plasma",{"measure":29,"description":30,"timeFrame":23},"Part 1: Maximum Concentration (Cmax) of anti-HER3 antibody LC-MS in plasma","Blood samples will be collected at specified intervals for the determination of Cmax.",{"measure":32,"description":30,"timeFrame":23},"Part 1: Cmax of anti-HER3-ac-DXd in plasma",{"measure":34,"description":30,"timeFrame":23},"Part 1: Cmax of DXd in plasma",{"measure":36,"description":37,"timeFrame":23},"Part 1: Concentration Immediately Before the Next Dose is Administered (Ctrough) of anti-HER3 antibody LC-MS in plasma","Blood samples will be collected at specified intervals for the determination of Ctrough.",{"measure":39,"description":37,"timeFrame":23},"Part 1: Ctrough of anti-HER3-ac-DXd",{"measure":41,"description":37,"timeFrame":23},"Part 1: Ctrough of DXd in plasma",{"measure":43,"description":44,"timeFrame":16},"Part 1 and Part 2: Objective Response Rate (ORR)","ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.",[46,48,50,53,56,59,62,65,67,69,71,73,75,77,79,81],{"measure":47,"description":15,"timeFrame":16},"Part 2: Percentage of Participants Who Experience an AE",{"measure":49,"description":19,"timeFrame":16},"Part 2: Percentage of Participants Who Discontinue Study Treatment Due to an AE",{"measure":51,"description":52,"timeFrame":16},"Part 1 and Part 2: Disease Control Rate (DCR)","DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm). Note: The appearance of one or more new lesions is also considered PD. The time from the first dose until the date of SD must be greater than or equal to 6 weeks. The DCR as assessed by the investigator will be presented.",{"measure":54,"description":55,"timeFrame":16},"Part 1 and Part 2: Time to Response (TTR)","For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, TTR is defined as the time from the first dose to the first documented evidence of a CR or PR. The TTR as assessed by the investigator will be presented.",{"measure":57,"description":58,"timeFrame":16},"Part 1 and Part 2: Duration of Response (DOR)","For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.",{"measure":60,"description":61,"timeFrame":16},"Part 1 and Part 2: Progression-free Survival (PFS)","PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented.",{"measure":63,"description":64,"timeFrame":16},"Part 1 and Part 2: Overall Survival (OS)","OS is defined as time from first dose of study treatment to death due to any cause.",{"measure":66,"description":22,"timeFrame":23},"Part 2: AUC of total anti-HER3 antibody LC-MS in plasma",{"measure":68,"description":22,"timeFrame":23},"Part 2: AUC of anti-HER3-ac-DXd in plasma",{"measure":70,"description":22,"timeFrame":23},"Part 2: AUC of DXd in plasma",{"measure":72,"description":30,"timeFrame":23},"Part 2: Cmax of anti-HER3 antibody LC-MS in plasma",{"measure":74,"description":30,"timeFrame":23},"Part 2: Cmax of anti-HER3-ac-DXd in plasma",{"measure":76,"description":30,"timeFrame":23},"Part 2: Cmax of DXd in plasma",{"measure":78,"description":37,"timeFrame":23},"Part 2: Ctrough of anti-HER3 antibody LC-MS in plasma",{"measure":80,"description":37,"timeFrame":23},"Part 2: Ctrough of anti-HER3-ac-DXd in plasma",{"measure":82,"description":37,"timeFrame":23},"Part 2: Ctrough of DXd in plasma",null,{"allocation":85,"interventionModel":86,"interventionModelDescription":83,"primaryPurpose":87,"observationalModel":83,"timePerspective":83,"maskingInfo":88},"NA","SINGLE_GROUP","TREATMENT",{"masking":89,"maskingDescription":83,"whoMasked":83},"NONE","This study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an efficacy evaluation (Part 2)",[92],{"label":93,"type":94,"description":95,"interventionNames":96},"Patritumab Deruxtecan","EXPERIMENTAL","Participants receive patritumab deruxtecan via IV infusion on Day 1 of each 3-week cycle until discontinuation or progression.",[97],"Biological: Patritumab Deruxtecan",[99],{"type":100,"name":93,"description":101,"armGroupLabels":102,"otherNames":103},"BIOLOGICAL","IV Infusion",[93],[104,105,106],"MK-1022","HER3-DXd","U3-1402",[108],{"name":109,"affiliation":5,"role":110},"Medical Director","STUDY_DIRECTOR",[112],{"name":113,"role":114,"phone":115,"phoneExt":83,"email":116},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[118,136,149,162,175,188,201,214,227,240,252,264,277,290,303,316,329,342,357,370,383,398,413,426,438,453,466,481,496,509,522,536,549,564,579,592,605,618,631,646,659,671,686,696,710,722,736,748,760,774,789,802,811,826,837,849,864,873,886,895,907,922,934,946],{"facility":119,"status":120,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"Childrens Hospital Los Angeles ( Site 3006)","RECRUITING","Los Angeles","California","90027","United States","US",{"type":127,"coordinates":128},"Point",[129,130],-118.24368,34.05223,{"lat":130,"lon":129},[133],{"name":134,"role":114,"phone":135,"phoneExt":83,"email":83},"Study Coordinator","323-361-2121",{"facility":137,"status":120,"city":138,"state":139,"zip":140,"country":124,"countryCode":125,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)","Aurora","Colorado","80045",{"type":127,"coordinates":142},[143,144],-104.83192,39.72943,{"lat":144,"lon":143},[147],{"name":134,"role":114,"phone":148,"phoneExt":83,"email":83},"720-777-1234",{"facility":150,"status":120,"city":151,"state":152,"zip":153,"country":124,"countryCode":125,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Yale New Haven Hospital ( Site 3012)","New Haven","Connecticut","06510",{"type":127,"coordinates":155},[156,157],-72.92816,41.30815,{"lat":157,"lon":156},[160],{"name":134,"role":114,"phone":161,"phoneExt":83,"email":83},"203-785-4640",{"facility":163,"status":120,"city":164,"state":165,"zip":166,"country":124,"countryCode":125,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Johns Hopkins All Children's Hospital ( Site 3025)","St. Petersburg","Florida","33701",{"type":127,"coordinates":168},[169,170],-82.67927,27.77086,{"lat":170,"lon":169},[173],{"name":134,"role":114,"phone":174,"phoneExt":83,"email":83},"727-767-4176",{"facility":176,"status":120,"city":177,"state":178,"zip":179,"country":124,"countryCode":125,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)","Iowa City","Iowa","52242",{"type":127,"coordinates":181},[182,183],-91.53017,41.66113,{"lat":183,"lon":182},[186],{"name":134,"role":114,"phone":187,"phoneExt":83,"email":83},"319-356-2296",{"facility":189,"status":120,"city":190,"state":191,"zip":192,"country":124,"countryCode":125,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Dana-Farber Cancer Institute ( Site 3013)","Boston","Massachusetts","02215",{"type":127,"coordinates":194},[195,196],-71.05977,42.35843,{"lat":196,"lon":195},[199],{"name":134,"role":114,"phone":200,"phoneExt":83,"email":83},"617-632-4580",{"facility":202,"status":120,"city":203,"state":204,"zip":205,"country":124,"countryCode":125,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Corewell Health ( Site 3001)","Grand Rapids","Michigan","49503",{"type":127,"coordinates":207},[208,209],-85.66809,42.96336,{"lat":209,"lon":208},[212],{"name":134,"role":114,"phone":213,"phoneExt":83,"email":83},"616-486-0746",{"facility":215,"status":120,"city":216,"state":217,"zip":218,"country":124,"countryCode":125,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Children's Mercy Hospital ( Site 3024)","Kansas City","Missouri","64108",{"type":127,"coordinates":220},[221,222],-94.57857,39.09973,{"lat":222,"lon":221},[225],{"name":134,"role":114,"phone":226,"phoneExt":83,"email":83},"816-302-6808",{"facility":228,"status":120,"city":229,"state":230,"zip":231,"country":124,"countryCode":125,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Rutgers Cancer Institute of New Jersey ( Site 3008)","New Brunswick","New Jersey","08901",{"type":127,"coordinates":233},[234,235],-74.45182,40.48622,{"lat":235,"lon":234},[238],{"name":134,"role":114,"phone":239,"phoneExt":83,"email":83},"732-235-2465",{"facility":241,"status":120,"city":242,"state":242,"zip":243,"country":124,"countryCode":125,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Memorial Sloan Kettering Cancer Center ( Site 3010)","New York","10065",{"type":127,"coordinates":245},[246,247],-74.00597,40.71427,{"lat":247,"lon":246},[250],{"name":134,"role":114,"phone":251,"phoneExt":83,"email":83},"888-492-8401",{"facility":253,"status":120,"city":254,"state":242,"zip":255,"country":124,"countryCode":125,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"New York Medical College ( Site 3023)","Valhalla","10595",{"type":127,"coordinates":257},[258,259],-73.77513,41.07482,{"lat":259,"lon":258},[262],{"name":134,"role":114,"phone":263,"phoneExt":83,"email":83},"914-614-4270",{"facility":265,"status":120,"city":266,"state":267,"zip":268,"country":124,"countryCode":125,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3003)","Fargo","North Dakota","58102",{"type":127,"coordinates":270},[271,272],-96.7898,46.87719,{"lat":272,"lon":271},[275],{"name":134,"role":114,"phone":276,"phoneExt":83,"email":83},"701-234-2000",{"facility":278,"status":120,"city":279,"state":280,"zip":281,"country":124,"countryCode":125,"cosmosGeoPoint":282,"geoPoint":286,"contacts":287},"Oregon Health and Science University ( Site 3004)","Portland","Oregon","97239",{"type":127,"coordinates":283},[284,285],-122.67621,45.52345,{"lat":285,"lon":284},[288],{"name":134,"role":114,"phone":289,"phoneExt":83,"email":83},"503-494-8311",{"facility":291,"status":120,"city":292,"state":293,"zip":294,"country":124,"countryCode":125,"cosmosGeoPoint":295,"geoPoint":299,"contacts":300},"Children's Hospital of Philadelphia (CHOP) ( Site 3021)","Philadelphia","Pennsylvania","19104",{"type":127,"coordinates":296},[297,298],-75.16362,39.95238,{"lat":298,"lon":297},[301],{"name":134,"role":114,"phone":302,"phoneExt":83,"email":83},"267-425-5544",{"facility":304,"status":120,"city":305,"state":306,"zip":307,"country":124,"countryCode":125,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"Sanford Children's Hospital ( Site 3015)","Sioux Falls","South Dakota","57117",{"type":127,"coordinates":309},[310,311],-96.72796,43.54369,{"lat":311,"lon":310},[314],{"name":134,"role":114,"phone":315,"phoneExt":83,"email":83},"605-312-1000",{"facility":317,"status":120,"city":318,"state":319,"zip":320,"country":124,"countryCode":125,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"University of Texas-MD Anderson Cancer Center ( Site 3007)","Houston","Texas","77030",{"type":127,"coordinates":322},[323,324],-95.36327,29.76328,{"lat":324,"lon":323},[327],{"name":134,"role":114,"phone":328,"phoneExt":83,"email":83},"713-792-5410",{"facility":330,"status":120,"city":331,"state":332,"zip":333,"country":124,"countryCode":125,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"Intermountain - Primary Children's Hospital ( Site 3014)","Salt Lake City","Utah","84113",{"type":127,"coordinates":335},[336,337],-111.89105,40.76078,{"lat":337,"lon":336},[340],{"name":134,"role":114,"phone":341,"phoneExt":83,"email":83},"801-662-4700",{"facility":343,"status":120,"city":344,"state":345,"zip":346,"country":347,"countryCode":348,"cosmosGeoPoint":349,"geoPoint":353,"contacts":354},"Sydney Children's Hospital-Kids Cancer Centre ( Site 3997)","Sydney","New South Wales","2031","Australia","AU",{"type":127,"coordinates":350},[351,352],151.20732,-33.86785,{"lat":352,"lon":351},[355],{"name":134,"role":114,"phone":356,"phoneExt":83,"email":83},"61293821111",{"facility":358,"status":120,"city":359,"state":360,"zip":361,"country":347,"countryCode":348,"cosmosGeoPoint":362,"geoPoint":366,"contacts":367},"Queensland Children's Hospital ( Site 3996)","Brisbane","Queensland","4101",{"type":127,"coordinates":363},[364,365],153.02809,-27.46794,{"lat":365,"lon":364},[368],{"name":134,"role":114,"phone":369,"phoneExt":83,"email":83},"61730681111",{"facility":371,"status":120,"city":372,"state":373,"zip":374,"country":347,"countryCode":348,"cosmosGeoPoint":375,"geoPoint":379,"contacts":380},"Royal Children's Hospital ( Site 3994)","Parkville","Victoria","3052",{"type":127,"coordinates":376},[377,378],144.95,-37.78333,{"lat":378,"lon":377},[381],{"name":134,"role":114,"phone":382,"phoneExt":83,"email":83},"61393455522",{"facility":384,"status":120,"city":385,"state":386,"zip":387,"country":388,"countryCode":389,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"UZ Gent ( Site 3428)","Ghent","Oost-Vlaanderen","9000","Belgium","BE",{"type":127,"coordinates":391},[392,393],3.71667,51.05,{"lat":393,"lon":392},[396],{"name":134,"role":114,"phone":397,"phoneExt":83,"email":83},"+3293324812",{"facility":399,"status":120,"city":400,"state":401,"zip":402,"country":403,"countryCode":404,"cosmosGeoPoint":405,"geoPoint":409,"contacts":410},"Hospital de Clinicas de Porto Alegre ( Site 3265)","Porto Alegre","Rio Grande do Sul","90035-903","Brazil","BR",{"type":127,"coordinates":406},[407,408],-51.23019,-30.03283,{"lat":408,"lon":407},[411],{"name":134,"role":114,"phone":412,"phoneExt":83,"email":83},"+5551980139616",{"facility":414,"status":120,"city":415,"state":416,"zip":417,"country":403,"countryCode":404,"cosmosGeoPoint":418,"geoPoint":422,"contacts":423},"Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3264)","Barretos","São Paulo","14784-400",{"type":127,"coordinates":419},[420,421],-48.56778,-20.55722,{"lat":421,"lon":420},[424],{"name":134,"role":114,"phone":425,"phoneExt":83,"email":83},"+551733216638",{"facility":427,"status":120,"city":428,"state":416,"zip":429,"country":403,"countryCode":404,"cosmosGeoPoint":430,"geoPoint":434,"contacts":435},"Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3267)","São José do Rio Preto","15090-000",{"type":127,"coordinates":431},[432,433],-49.37944,-20.81972,{"lat":433,"lon":432},[436],{"name":134,"role":114,"phone":437,"phoneExt":83,"email":83},"+55 17 99625-3919",{"facility":439,"status":120,"city":440,"state":441,"zip":442,"country":443,"countryCode":444,"cosmosGeoPoint":445,"geoPoint":449,"contacts":450},"Alberta Children's Hospital ( Site 3227)","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":127,"coordinates":446},[447,448],-114.08529,51.05011,{"lat":448,"lon":447},[451],{"name":134,"role":114,"phone":452,"phoneExt":83,"email":83},"403-955-7203",{"facility":454,"status":120,"city":455,"state":456,"zip":457,"country":443,"countryCode":444,"cosmosGeoPoint":458,"geoPoint":462,"contacts":463},"The Hospital for Sick Children ( Site 3225)","Toronto","Ontario","M5G 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