[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595304":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":57,"centralContacts":61,"locations":68,"responsibleParty":141,"collaborators":66,"id":143,"slug":66,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":66,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":66,"enrollmentInfo":151,"targetDuration":66,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":71,"whyStopped":66,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Drug: MK-8294","Other: CD8 PET Tracer",[16,22,26,30,34,38,42,46,50],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","30 µg via intravenous (IV) infusion",[9],[21],"DAB014236",{"type":17,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"100 µg via intravenous (IV) infusion",[9],[21],{"type":17,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"300 µg via intravenous (IV) infusion",[9],[21],{"type":17,"name":9,"description":31,"armGroupLabels":32,"otherNames":33},"1 mg via intravenous (IV) infusion",[9],[21],{"type":17,"name":9,"description":35,"armGroupLabels":36,"otherNames":37},"3 mg via intravenous (IV) infusion",[9],[21],{"type":17,"name":9,"description":39,"armGroupLabels":40,"otherNames":41},"10 mg via intravenous (IV) infusion",[9],[21],{"type":17,"name":9,"description":43,"armGroupLabels":44,"otherNames":45},"30 mg via intravenous (IV) infusion",[9],[21],{"type":17,"name":9,"description":47,"armGroupLabels":48,"otherNames":49},"70 mg via intravenous (IV) infusion",[9],[21],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"OTHER","CD8 PET Tracer","IV Infusion",[9],[56],"GEH200520 + GEH200521 (18F)",[58],{"name":59,"affiliation":5,"role":60},"Medical Director","STUDY_DIRECTOR",[62],{"name":63,"role":64,"phone":65,"phoneExt":66,"email":67},"Toll Free Number","CONTACT","1-888-577-8839",null,"Trialsites@msd.com",[69,87,101,113,128],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Northwestern University ( Site 0101)","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-87.65005,41.85003,{"lat":81,"lon":80},[84],{"name":85,"role":64,"phone":86,"phoneExt":66,"email":66},"Study Coordinator","312-926-8105",{"facility":88,"status":71,"city":89,"state":66,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Rambam Health Care Campus ( Site 0201)","Haifa","3109601","Israel","IL",{"type":78,"coordinates":94},[95,96],34.99928,32.81303,{"lat":96,"lon":95},[99],{"name":85,"role":64,"phone":100,"phoneExt":66,"email":66},"972(47776234)",{"facility":102,"status":71,"city":103,"state":66,"zip":104,"country":91,"countryCode":92,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Sheba Medical Center ( Site 0200)","Ramat Gan","5265601",{"type":78,"coordinates":106},[107,108],34.81065,32.08227,{"lat":108,"lon":107},[111],{"name":85,"role":64,"phone":112,"phoneExt":66,"email":66},"972(35307039)",{"facility":114,"status":71,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Radboudumc ( Site 0301)","Nijmegen","Gelderland","6525 GA","Netherlands","NL",{"type":78,"coordinates":121},[122,123],5.85278,51.8425,{"lat":123,"lon":122},[126],{"name":85,"role":64,"phone":127,"phoneExt":66,"email":66},"0243611111",{"facility":129,"status":71,"city":130,"state":131,"zip":132,"country":118,"countryCode":119,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300)","Amsterdam","North Holland","1066 CX",{"type":78,"coordinates":134},[135,136],4.88969,52.37403,{"lat":136,"lon":135},[139],{"name":85,"role":64,"phone":140,"phoneExt":66,"email":66},"+31205129111",{"type":142,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","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":152,"type":153},67,"ESTIMATED","INTERVENTIONAL",[156],"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.",[159],"Metastatic Neoplasm",[161,162],"Metastases","Neoplasm","2026-03-12",{"date":165,"type":166},"2026-03-16","ACTUAL",{"date":168,"type":166},"2025-07-23",{"date":170,"type":153},"2027-08-23",{"name":5,"class":6},5]