[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595304":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":50,"interventions":58,"overallOfficials":100,"centralContacts":104,"locations":110,"responsibleParty":209,"collaborators":43,"id":211,"slug":212,"hasResults":213,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":43,"eligibilityCriteria":217,"healthyVolunteers":213,"sex":218,"minAge":219,"maxAge":43,"enrollmentInfo":220,"targetDuration":43,"studyType":223,"phases":224,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":113,"whyStopped":43,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":43},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Number of participants who experience one or more dose-limiting toxicities (DLTs)","DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period (up to 35 days) that results in a change to a given dose or a delay in initiating the next treatment and reported as the number of participants experiencing a DLT.","Up to approximately 35 days",{"measure":14,"description":15,"timeFrame":16},"Number of Participants Who Experience an Adverse Event (AE)","An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.","Up to approximately 2 years",{"measure":18,"description":19,"timeFrame":16},"Number of Participants Who Discontinue Study Intervention Due to an AE","An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study\u002Fstudy treatment due to an AE will be reported.",[21,24,28,31,34,37,40],{"measure":22,"description":23,"timeFrame":16},"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). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.",{"measure":25,"description":26,"timeFrame":27},"Area Under the Plasma Concentration-Time Curve (AUC) of MK-8294","Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Area Under the Concentration-Time Curve of MK-8294.","Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)",{"measure":29,"description":30,"timeFrame":27},"Minimum Concentration (Cmin) of MK-8294","Cmin is defined as the lowest concentration of MK-8294 after administration of MK-8294. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Cmin of MK-8294.",{"measure":32,"description":33,"timeFrame":27},"Maximum Plasma Concentration (Cmax) of MK-8294","Cmax is defined as the peak concentration of MK-8294 after administration of MK-8294. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Cmax of MK-8294.",{"measure":35,"description":36,"timeFrame":27},"Time to Maximum Plasma Concentration (Tmax) of MK-8294","Tmax is defined as the time to reach Cmax. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Tmax of MK-8294.",{"measure":38,"description":39,"timeFrame":27},"Incidence of Antidrug Antibodies (ADA) to MK-8294","Blood samples will be collected pre-dose and at designated time points to determine the ADA response to MK-8294. The incidence of ADAs over time will be presented.",{"measure":41,"description":42,"timeFrame":27},"Titer of ADA to MK-8294","Blood samples will be collected pre-dose and at designated time points to determine the ADA titers to MK-8294.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"NA","SEQUENTIAL","TREATMENT",{"masking":49,"maskingDescription":43,"whoMasked":43},"NONE",[51],{"label":52,"type":53,"description":54,"interventionNames":55},"MK-8294","EXPERIMENTAL","Participants will receive MK-8294 monotherapy in escalating doses starting from 30 µg up to a planned 70 mg via intravenous (IV) infusion. In addition, intermediate doses may also be assessed. MK-8294 will be administered on Day 1, Day 8, and Day 15 of each cycle (each cycle = 21 days). Per protocol treatment of MK-8294 has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met. Participants may also receive a cluster of differentiation 8 (CD8) positron emission tomography (PET) tracer as a part of optional PET imaging.",[56,57],"Drug: MK-8294","Other: CD8 PET Tracer",[59,65,69,73,77,81,85,89,93],{"type":60,"name":52,"description":61,"armGroupLabels":62,"otherNames":63},"DRUG","30 µg via intravenous (IV) infusion",[52],[64],"DAB014236",{"type":60,"name":52,"description":66,"armGroupLabels":67,"otherNames":68},"100 µg via intravenous (IV) infusion",[52],[64],{"type":60,"name":52,"description":70,"armGroupLabels":71,"otherNames":72},"300 µg via intravenous (IV) infusion",[52],[64],{"type":60,"name":52,"description":74,"armGroupLabels":75,"otherNames":76},"1 mg via intravenous (IV) infusion",[52],[64],{"type":60,"name":52,"description":78,"armGroupLabels":79,"otherNames":80},"3 mg via intravenous (IV) infusion",[52],[64],{"type":60,"name":52,"description":82,"armGroupLabels":83,"otherNames":84},"10 mg via intravenous (IV) infusion",[52],[64],{"type":60,"name":52,"description":86,"armGroupLabels":87,"otherNames":88},"30 mg via intravenous (IV) infusion",[52],[64],{"type":60,"name":52,"description":90,"armGroupLabels":91,"otherNames":92},"70 mg via intravenous (IV) infusion",[52],[64],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"OTHER","CD8 PET Tracer","IV Infusion",[52],[99],"GEH200520 + GEH200521 (18F)",[101],{"name":102,"affiliation":5,"role":103},"Medical Director","STUDY_DIRECTOR",[105],{"name":106,"role":107,"phone":108,"phoneExt":43,"email":109},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[111,129,142,155,169,181,196],{"facility":112,"status":113,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"Northwestern University ( Site 0101)","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":120,"coordinates":121},"Point",[122,123],-87.65005,41.85003,{"lat":123,"lon":122},[126],{"name":127,"role":107,"phone":128,"phoneExt":43,"email":43},"Study Coordinator","312-926-8105",{"facility":130,"status":113,"city":131,"state":132,"zip":133,"country":117,"countryCode":118,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"John Theurer Cancer Center at Hackensack University Medical Center ( Site 0105)","Hackensack","New Jersey","07601",{"type":120,"coordinates":135},[136,137],-74.04347,40.88593,{"lat":137,"lon":136},[140],{"name":127,"role":107,"phone":141,"phoneExt":43,"email":43},"551-996-5900",{"facility":143,"status":113,"city":144,"state":145,"zip":146,"country":117,"countryCode":118,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Houston Methodist Hospital ( Site 0103)","Houston","Texas","77030",{"type":120,"coordinates":148},[149,150],-95.36327,29.76328,{"lat":150,"lon":149},[153],{"name":127,"role":107,"phone":154,"phoneExt":43,"email":43},"346-238-4516",{"facility":156,"status":113,"city":157,"state":43,"zip":158,"country":159,"countryCode":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Rambam Health Care Campus ( Site 0201)","Haifa","3109601","Israel","IL",{"type":120,"coordinates":162},[163,164],34.99928,32.81303,{"lat":164,"lon":163},[167],{"name":127,"role":107,"phone":168,"phoneExt":43,"email":43},"972(47776234)",{"facility":170,"status":113,"city":171,"state":43,"zip":172,"country":159,"countryCode":160,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Sheba Medical Center ( Site 0200)","Ramat Gan","5265601",{"type":120,"coordinates":174},[175,176],34.81065,32.08227,{"lat":176,"lon":175},[179],{"name":127,"role":107,"phone":180,"phoneExt":43,"email":43},"972(35307039)",{"facility":182,"status":113,"city":183,"state":184,"zip":185,"country":186,"countryCode":187,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Radboudumc ( Site 0301)","Nijmegen","Gelderland","6525 GA","Netherlands","NL",{"type":120,"coordinates":189},[190,191],5.85278,51.8425,{"lat":191,"lon":190},[194],{"name":127,"role":107,"phone":195,"phoneExt":43,"email":43},"0243611111",{"facility":197,"status":113,"city":198,"state":199,"zip":200,"country":186,"countryCode":187,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300)","Amsterdam","North Holland","1066 CX",{"type":120,"coordinates":202},[203,204],4.88969,52.37403,{"lat":204,"lon":203},[207],{"name":127,"role":107,"phone":208,"phoneExt":43,"email":43},"+31205129111",{"type":210,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100595304","phase-1-a-clinical-study-of-mk-8294-in-participants-with-advanced-solid-tumors-mk-8294-001-100595304",false,"NCT07030712","A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)","A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-8294 Monotherapy in Advanced Solid Tumors","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically or cytologically confirmed advanced\u002Fmetastatic solid tumor; including head and neck squamous cell carcinoma, cervical squamous cell carcinoma, esophageal squamous cell carcinoma, breast cancer (triple negative breast cancer, Estrogen Receptor \\[ER\\]\u002Fprogesterone receptor +, human epidermal growth factor receptor 2 negative \\[HER2-\\]), endometrial, and bladder cancer by pathology report and have previously failed standard treatment, lack standard treatment options, or are intolerant to standard treatment\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has a history of New York Heart Association Class II or greater heart failure\n* Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis\n* Has ongoing radiation-related toxicities, requiring corticosteroids\n* Has known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)\n* Has active infection requiring systemic therapy\n* Has history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or have ongoing surgical complications","ALL","18 Years",{"count":221,"type":222},67,"ESTIMATED","INTERVENTIONAL",[225],"PHASE1","MK-8294, the study medicine, is a type of targeted therapy designed to treat certain solid tumors. The main goals of this study are to learn about the safety of MK-8294 and if people can tolerate it and find the highest dose level of MK-8294 that people can tolerate.",[228],"Metastatic Neoplasm",[230,231],"Metastases","Neoplasm","2026-09-09",{"date":234,"type":235},"2026-09-11","ACTUAL",{"date":237,"type":235},"2025-07-23",{"date":239,"type":222},"2029-07-01",{"name":5,"class":6},7]