[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576042":3},{"organization":4,"outcomesModule":7,"designInfo":172,"detailedDescription":179,"studyPopulation":171,"armGroups":180,"interventions":219,"overallOfficials":237,"centralContacts":241,"locations":247,"responsibleParty":834,"collaborators":836,"id":839,"slug":840,"hasResults":841,"nctId":842,"briefTitle":843,"officialTitle":844,"acronym":171,"eligibilityCriteria":845,"healthyVolunteers":841,"sex":846,"minAge":847,"maxAge":171,"enrollmentInfo":848,"targetDuration":171,"studyType":851,"phases":852,"briefSummary":855,"conditions":856,"keywords":171,"overallStatus":250,"whyStopped":171,"lastUpdateSubmitDate":858,"lastUpdatePostDateStruct":859,"startDateStruct":862,"completionDateStruct":864,"leadSponsor":866,"locationsCount":867},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":171},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Number 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 number of participants who experience an AE in the study will be presented.","Up to approximately 44 months",{"measure":14,"description":15,"timeFrame":16},"Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)","A DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that meet pre-defined DTL criteria. Toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0, or the American Society for Transplant and Cellular Therapy (ASTCT) criteria. The number of participants who experience at least one DLT will be presented.","Up to approximately 3 weeks",{"measure":18,"description":19,"timeFrame":12},"Number of Participants Who Discontinue Study Intervention 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 number of participants who discontinue the study intervention due to an AE in the study will be presented.",{"measure":21,"description":22,"timeFrame":12},"Part 1: 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.",[24,27,30,32,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78,81,84,87,90,93,96,99,102,105,108,111,114,117,120,123,126,129,132,135,138,141,144,147,150,153,156,159,162,165,168],{"measure":25,"description":26,"timeFrame":12},"Part 1, Part 2 (Arm 5, Arm 6, and Arm 8), and Part 3 (Arm 7): Duration of Response (DOR)","For participants who demonstrate a confirmed 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 RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.",{"measure":28,"description":29,"timeFrame":12},"Part 1, Part 2 (Arm 6 and Arm 8), and Part 3 (Arm 7): 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 ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented.",{"measure":31,"description":22,"timeFrame":12},"Part 2 (Arm 5, Arm 6, and Arm 8) and Part 3 (Arm 7): ORR",{"measure":33,"description":34,"timeFrame":35},"Maximum Concentration (Cmax) of gocatamig","Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug gocatamig.","At designated timepoints (up to approximately 44 months)",{"measure":37,"description":38,"timeFrame":35},"Cmax of ifinatamab deruxtecan (I-DXd)","Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug I-DXd.",{"measure":40,"description":41,"timeFrame":35},"Cmax of Anti-B7-H3 Antibody","Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the anti-B7-H3 antibody.",{"measure":43,"description":44,"timeFrame":35},"Cmax of Deruxtecan (DXd)","Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug payload deruxtecan (DXd).",{"measure":46,"description":47,"timeFrame":35},"Cmax of Durvalumab","Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of durvalumab.",{"measure":49,"description":50,"timeFrame":35},"Time to maximum concentration (Tmax) of gocatamig","Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug gocatamig.",{"measure":52,"description":53,"timeFrame":35},"Tmax of I-DXd","Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug I-DXd.",{"measure":55,"description":56,"timeFrame":35},"Tmax of Anti-B7-H3 Antibody","Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the anti-B7-H3 antibody.",{"measure":58,"description":59,"timeFrame":35},"Tmax of DXd","Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug payload DXd.",{"measure":61,"description":62,"timeFrame":35},"Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of gocatamig","AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug gocatamig.",{"measure":64,"description":65,"timeFrame":35},"AUCt of I-DXd","AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug I-DXd.",{"measure":67,"description":68,"timeFrame":35},"AUCt of Anti-B7-H3 Antibody","AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the anti-B7-H3 antibody.",{"measure":70,"description":71,"timeFrame":35},"AUCt of DXd","AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug payload Dxd.",{"measure":73,"description":74,"timeFrame":35},"Terminal Half-Life (t1\u002F2) of gocatamig","t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1\u002F2 of the drug gocatamig.",{"measure":76,"description":77,"timeFrame":35},"t1\u002F2 of I-DXd","t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1\u002F2 of the drug I-DXd.",{"measure":79,"description":80,"timeFrame":35},"t1\u002F2 of Anti-B7-H3 Antibody","t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1\u002F2 of the anti-B7-H3 antibody.",{"measure":82,"description":83,"timeFrame":35},"t1\u002F2 of DXd","t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1\u002F2 of the drug payload DXd.",{"measure":85,"description":86,"timeFrame":35},"Steady State Maximum Concentration (Cmax,ss) of gocatamig","Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug gocatamig.",{"measure":88,"description":89,"timeFrame":35},"Cmax,ss of I-DXd","Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug I-DXd.",{"measure":91,"description":92,"timeFrame":35},"Cmax,ss of Anti-B7-H3 Antibody","Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the anti-B7-H3 antibody.",{"measure":94,"description":95,"timeFrame":35},"Cmax,ss of DXd","Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug payload DXd.",{"measure":97,"description":98,"timeFrame":35},"Cmax,ss of Durvalumab","Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the durvalumab.",{"measure":100,"description":101,"timeFrame":35},"Steady State Ctrough (Ctrough,ss) of gocatamig","Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug gocatamig.",{"measure":103,"description":104,"timeFrame":35},"Ctrough,ss of I-DXd","Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug I-DXd.",{"measure":106,"description":107,"timeFrame":35},"Ctrough,ss of Anti-B7-H3 Antibody","Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the anti-B7-H3 antibody.",{"measure":109,"description":110,"timeFrame":35},"Ctrough,ss of DXd","Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug payload DXd.",{"measure":112,"description":113,"timeFrame":35},"Ctrough,ss of Durvalumab","Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of durvalumab.",{"measure":115,"description":116,"timeFrame":35},"Steady State Time to Maximum Concentration (Tmax,ss) of gocatamig","Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug gocatamig.",{"measure":118,"description":119,"timeFrame":35},"Tmax,ss of I-DXd","Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug I-DXd.",{"measure":121,"description":122,"timeFrame":35},"Tmax,ss of Anti-B7-H3 Antibody","Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the anti-B7-H3 antibody.",{"measure":124,"description":125,"timeFrame":35},"Tmax,ss of DXd","Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug payload DXd.",{"measure":127,"description":128,"timeFrame":35},"Area Under the Steady State Concentration-Time Curve Over Dosing Interval t (AUCt,ss) of gocatamig","AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug gocatamig.",{"measure":130,"description":131,"timeFrame":35},"AUCt,ss of I-DXd","AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug I-DXd.",{"measure":133,"description":134,"timeFrame":35},"AUCt,ss of Anti-B7-H3 Antibody","AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the anti-B7-H3 antibody.",{"measure":136,"description":137,"timeFrame":35},"AUCt,ss of DXd","AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug payload DXd.",{"measure":139,"description":140,"timeFrame":35},"Steady state t1\u002F2 (t1\u002F2,ss) of gocatamig","t1\u002F2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1\u002F2,ss of the drug gocatamig.",{"measure":142,"description":143,"timeFrame":35},"t1\u002F2,ss of I-DXd","t1\u002F2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1\u002F2,ss of the drug I-DXd.",{"measure":145,"description":146,"timeFrame":35},"t1\u002F2,ss of Anti-B7-H3 Antibody","t1\u002F2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1\u002F2,ss of the anti-B7-H3 antibody.",{"measure":148,"description":149,"timeFrame":35},"t1\u002F2,ss of DXd","t1\u002F2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1\u002F2,ss of the drug payload DXd.",{"measure":151,"description":152,"timeFrame":35},"Accumulation Ratio (AC) of gocatamig","Blood samples will be collected to determine the AC of the drug gocatamig.",{"measure":154,"description":155,"timeFrame":35},"AC of I-DXd","Blood samples will be collected to determine the AC of the drug I-DXd.",{"measure":157,"description":158,"timeFrame":35},"AC of Anti-B7-H3 Antibody","Blood samples will be collected to determine the AC of the anti-B7-H3 antibody.",{"measure":160,"description":161,"timeFrame":35},"AC of DXd","Blood samples will be collected to determine the AC of the drug payload DXd.",{"measure":163,"description":164,"timeFrame":35},"Incidence of Anti-Drug Antibodies (ADAs) Against gocatamig","Blood samples collected at designated timepoints will be used to determine the ADA response to gocatamig. The incidence of ADAs for gocatamig will be presented.",{"measure":166,"description":167,"timeFrame":35},"Incidence of ADAs Against I-DXd","Blood samples collected at designated timepoints will be used to determine the ADA response to I-DXd. The incidence of ADAs for I-DXd will be presented.",{"measure":169,"description":170,"timeFrame":35},"Incidence of ADAs Against Durvalumab","Blood samples collected at designated timepoints will be used to determine the ADA response to durvalumab. The incidence of ADAs for durvalumab will be presented.",null,{"allocation":173,"interventionModel":174,"interventionModelDescription":175,"primaryPurpose":176,"observationalModel":171,"timePerspective":171,"maskingInfo":177},"RANDOMIZED","PARALLEL","Part 1 consists of four arms (gocatamig and I-DXd at different dosing intervals). Participants will be randomized to one of the four arms using an interactive response technology (IRT) system. Part 2 consists of four arms (gocatamig monotherapy in participants in Japan, gocatamig monotherapy in participants in China, and gocatamig evaluated at different dosing intervals across two additional study arms). Part 3 consists of a single arm (gocatamig and durvalumab).","TREATMENT",{"masking":178,"maskingDescription":171,"whoMasked":171},"NONE","This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.",[181,188,191,195,198,202,206,210,215],{"label":182,"type":183,"description":184,"interventionNames":185},"Part 1 Arm 1: Gocatamig and I-DXd","EXPERIMENTAL","Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.",[186,187],"Biological: Gocatamig","Biological: Ifinatamab Deruxtecan (I-DXd)",{"label":189,"type":183,"description":184,"interventionNames":190},"Part 1 Arm 2: Gocatamig and I-DXd",[186,187],{"label":192,"type":183,"description":193,"interventionNames":194},"Part 1 Arm 3a: I-DXd Monotherapy","Participants will receive I-DXd until documented disease progression or discontinuation criteria are met.",[187],{"label":196,"type":183,"description":184,"interventionNames":197},"Part 1 Arm 3b: Gocatamig and I-DXd",[186,187],{"label":199,"type":183,"description":200,"interventionNames":201},"Part 2 Arm 4: Gocatamig Monotherapy in Japan","Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.",[186],{"label":203,"type":183,"description":204,"interventionNames":205},"Part 2 Arm 5: Gocatamig Monotherapy in China","Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.",[186],{"label":207,"type":183,"description":208,"interventionNames":209},"Part 2 Arm 6: Gocatamig","Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.",[186],{"label":211,"type":183,"description":212,"interventionNames":213},"Part 3 Arm 7: Gocatamig and Durvalumab","Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met.",[186,214],"Biological: Durvalumab",{"label":216,"type":183,"description":217,"interventionNames":218},"Part 2 Arm 8: Gocatamig (Alternate Presentation)","Participants will receive an alternate presentation of gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.",[186],[220,228,234],{"type":221,"name":222,"description":223,"armGroupLabels":224,"otherNames":225},"BIOLOGICAL","Gocatamig","IV infusion",[182,189,196,199,203,207,216,211],[226,227],"HPN328","MK-6070",{"type":221,"name":229,"description":223,"armGroupLabels":230,"otherNames":231},"Ifinatamab Deruxtecan (I-DXd)",[182,189,192,196],[232,233],"DS-7300a","MK-2400",{"type":221,"name":235,"description":223,"armGroupLabels":236,"otherNames":171},"Durvalumab",[211],[238],{"name":239,"affiliation":5,"role":240},"Medical Director","STUDY_DIRECTOR",[242],{"name":243,"role":244,"phone":245,"phoneExt":171,"email":246},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[248,266,279,292,305,318,331,344,357,370,385,398,413,426,441,450,459,474,487,500,513,522,535,548,560,572,584,596,611,624,637,645,658,667,676,691,703,716,727,735,744,756,770,782,795,804,816,825],{"facility":249,"status":250,"city":251,"state":252,"zip":253,"country":254,"countryCode":255,"cosmosGeoPoint":256,"geoPoint":261,"contacts":262},"University of Colorado Anschutz Medical Campus ( Site 1110)","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":257,"coordinates":258},"Point",[259,260],-104.83192,39.72943,{"lat":260,"lon":259},[263],{"name":264,"role":244,"phone":265,"phoneExt":171,"email":171},"Study Coordinator","303-724-6268",{"facility":267,"status":250,"city":268,"state":269,"zip":270,"country":254,"countryCode":255,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)","Miami","Florida","33136",{"type":257,"coordinates":272},[273,274],-80.19366,25.77427,{"lat":274,"lon":273},[277],{"name":264,"role":244,"phone":278,"phoneExt":171,"email":171},"305-243-1754",{"facility":280,"status":250,"city":281,"state":282,"zip":283,"country":254,"countryCode":255,"cosmosGeoPoint":284,"geoPoint":288,"contacts":289},"University of Chicago ( Site 1108)","Chicago","Illinois","60637",{"type":257,"coordinates":285},[286,287],-87.65005,41.85003,{"lat":287,"lon":286},[290],{"name":264,"role":244,"phone":291,"phoneExt":171,"email":171},"773-702-6149",{"facility":293,"status":250,"city":294,"state":295,"zip":296,"country":254,"countryCode":255,"cosmosGeoPoint":297,"geoPoint":301,"contacts":302},"Dana Farber Cancer Institute ( Site 1105)","Boston","Massachusetts","02215",{"type":257,"coordinates":298},[299,300],-71.05977,42.35843,{"lat":300,"lon":299},[303],{"name":264,"role":244,"phone":304,"phoneExt":171,"email":171},"617-632-6049",{"facility":306,"status":250,"city":307,"state":308,"zip":309,"country":254,"countryCode":255,"cosmosGeoPoint":310,"geoPoint":314,"contacts":315},"John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)","Hackensack","New Jersey","07601",{"type":257,"coordinates":311},[312,313],-74.04347,40.88593,{"lat":313,"lon":312},[316],{"name":264,"role":244,"phone":317,"phoneExt":171,"email":171},"551-996-5863",{"facility":319,"status":250,"city":320,"state":321,"zip":322,"country":254,"countryCode":255,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"Roswell Park Cancer Institute ( Site 1107)","Buffalo","New York","14263",{"type":257,"coordinates":324},[325,326],-78.87837,42.88645,{"lat":326,"lon":325},[329],{"name":264,"role":244,"phone":330,"phoneExt":171,"email":171},"716-845-3167",{"facility":332,"status":250,"city":333,"state":334,"zip":335,"country":254,"countryCode":255,"cosmosGeoPoint":336,"geoPoint":340,"contacts":341},"Providence Portland Medical Center ( Site 1101)","Portland","Oregon","97213",{"type":257,"coordinates":337},[338,339],-122.67621,45.52345,{"lat":339,"lon":338},[342],{"name":264,"role":244,"phone":343,"phoneExt":171,"email":171},"503-215-5696",{"facility":345,"status":250,"city":346,"state":347,"zip":348,"country":254,"countryCode":255,"cosmosGeoPoint":349,"geoPoint":353,"contacts":354},"Sarah Cannon Research Institute ( Site 7001)","Nashville","Tennessee","37203",{"type":257,"coordinates":350},[351,352],-86.78444,36.16589,{"lat":352,"lon":351},[355],{"name":264,"role":244,"phone":356,"phoneExt":171,"email":171},"844-482-4812",{"facility":358,"status":250,"city":359,"state":360,"zip":361,"country":254,"countryCode":255,"cosmosGeoPoint":362,"geoPoint":366,"contacts":367},"Medical College of Wisconsin ( Site 1112)","Milwaukee","Wisconsin","53226",{"type":257,"coordinates":363},[364,365],-87.90647,43.0389,{"lat":365,"lon":364},[368],{"name":264,"role":244,"phone":369,"phoneExt":171,"email":171},"414-805-8900",{"facility":371,"status":250,"city":372,"state":373,"zip":374,"country":375,"countryCode":376,"cosmosGeoPoint":377,"geoPoint":381,"contacts":382},"Hospital Universitario Austral ( Site 2204)","Pilar","Buenos Aires","B1629WWA","Argentina","AR",{"type":257,"coordinates":378},[379,380],-58.91398,-34.45867,{"lat":380,"lon":379},[383],{"name":264,"role":244,"phone":384,"phoneExt":171,"email":171},"+5402304482000",{"facility":386,"status":250,"city":387,"state":388,"zip":389,"country":375,"countryCode":376,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Sanatorio Parque ( Site 2203)","Rosario","Santa Fe Province","S2000DSV",{"type":257,"coordinates":391},[392,393],-60.63932,-32.94682,{"lat":393,"lon":392},[396],{"name":264,"role":244,"phone":397,"phoneExt":171,"email":171},"+5493416955611",{"facility":399,"status":250,"city":400,"state":401,"zip":402,"country":403,"countryCode":404,"cosmosGeoPoint":405,"geoPoint":409,"contacts":410},"Princess Alexandra Hospital ( Site 5300)","Woolloongabba","Queensland","4102","Australia","AU",{"type":257,"coordinates":406},[407,408],153.03655,-27.48855,{"lat":408,"lon":407},[411],{"name":264,"role":244,"phone":412,"phoneExt":171,"email":171},"+61731766577",{"facility":414,"status":250,"city":415,"state":416,"zip":417,"country":403,"countryCode":404,"cosmosGeoPoint":418,"geoPoint":422,"contacts":423},"Monash Health ( Site 5301)","Clayton","Victoria","3168",{"type":257,"coordinates":419},[420,421],145.11667,-37.91667,{"lat":421,"lon":420},[424],{"name":264,"role":244,"phone":425,"phoneExt":171,"email":171},"+61417607416",{"facility":427,"status":250,"city":428,"state":429,"zip":430,"country":431,"countryCode":432,"cosmosGeoPoint":433,"geoPoint":437,"contacts":438},"FALP ( Site 2100)","Santiago","Region M. de 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confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a\u002Fb\u002Fc) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy\n* Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\n* Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure\n* Any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids\n* Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART\n* History within 6 months before the first dose of study intervention of coronary\u002Fperipheral artery bypass graft and\u002For any coronary\u002Fperipheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association \\> class II), and\u002For uncontrolled cardiac arrhythmia\n* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention\n* Active clinically significant infection requiring systemic therapy\n* History of allogeneic tissue\u002Fsolid organ transplant\n* History of leptomeningeal disease\n* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Untreated or symptomatic brain metastases\n* Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M \\[IgM\\] positive in the setting of associated signs\u002Fsymptoms), hepatitis B (hepatitis B virus surface antigen \\[HbsAg\\] positive and\u002For detectable hepatitis B virus \\[HBV\\] deoxyribonucleic acid \\[DNA\\]), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible.\n* Part 1 only: Radiation therapy to the lung \\>30 Gy within 6 months before the start of study intervention\n* Part 1 only: Abdominal radiation within 4 weeks before start of study intervention\n* Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone \\[LHRH\\]) within 2 weeks before start of study intervention\n* Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer\n* Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention\n* Part 1 only: Chloroquine\u002Fhydroxychloroquine within 2 weeks before start of study intervention\n* Part 1 only: Clinically significant corneal disease\n* Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease","ALL","18 Years",{"count":849,"type":850},327,"ESTIMATED","INTERVENTIONAL",[853,854],"PHASE1","PHASE2","Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment.\n\nThe goals of this study are to learn:\n\n* If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated\n* If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away",[857],"Small Cell Lung Cancer","2026-10-05",{"date":860,"type":861},"2026-10-06","ACTUAL",{"date":863,"type":861},"2025-02-27",{"date":865,"type":850},"2029-02-15",{"name":5,"class":6},48]