[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653224":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":48,"interventions":66,"overallOfficials":104,"centralContacts":108,"locations":114,"responsibleParty":172,"collaborators":41,"id":174,"slug":175,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":41,"eligibilityCriteria":180,"healthyVolunteers":176,"sex":181,"minAge":182,"maxAge":41,"enrollmentInfo":183,"targetDuration":41,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":41,"overallStatus":117,"whyStopped":41,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":41},[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.","Up to approximately 27 months",{"measure":14,"description":15,"timeFrame":16},"Number of Participants Who Experience Dose Limiting Toxicity (DLT) (Part 1 Only)","DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose.","Up to approximately 28 days",{"measure":18,"description":11,"timeFrame":19},"Number of Participants Who Discontinued Study Intervention Due to an AE","Up to approximately 24 months",{"measure":21,"description":22,"timeFrame":23},"Objective Response Rate (ORR)","ORR is defined as 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, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).","Up to approximately 60 months",[25,28,32,35,38],{"measure":26,"description":27,"timeFrame":23},"Duration of Response (DOR)","DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.",{"measure":29,"description":30,"timeFrame":31},"Area Under the Concentration-Time Curve (AUC) of MK-2010","Blood samples will be collected at designated timepoints to estimate the AUC of MK-2010.","Predose and at designated time points post-dose (up to approximately 24 months)",{"measure":33,"description":34,"timeFrame":31},"Trough Concentration (Ctrough) of MK-2010","Blood samples will be collected at designated timepoints to estimate the Ctrough of MK-2010.",{"measure":36,"description":37,"timeFrame":31},"Maximum Plasma Concentration (Cmax) of MK-2010","Blood samples will be collected at designated timepoints to estimate the Cmax of MK-2010.",{"measure":39,"description":40,"timeFrame":31},"Incidence of Antidrug Antibodies (ADA) to MK-2010","Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable ADAs to MK-2010.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE",[49,62],{"label":50,"type":51,"description":52,"interventionNames":53},"Part 1: Safety Lead-In Cohort","EXPERIMENTAL","Participants will receive MK-2010 in combination with sac-TMT.",[54,55,56,57,58,59,60,61],"Biological: MK-2010","Biological: Sacituzumab tirumotecan","Drug: Histamine H1 Receptor Antagonist","Drug: Histamine H2 Receptor Antagonist","Drug: Acetaminophen (or equivalent)","Drug: Dexamethasone (or equivalent)","Drug: Steroid mouthwash (dexamethasone or equivalent)","Drug: Epinephrine",{"label":63,"type":51,"description":64,"interventionNames":65},"Part 2: Signal-Finding Cohorts","Participants will receive MK-2010 in combination with sac-TMT at the dose determined in Part 1.",[54,55,56,57,58,59,60,61],[67,74,82,87,90,93,96,100],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"BIOLOGICAL","MK-2010","Administered as an intravenous (IV) infusion",[50,63],[73],"LM-299",{"type":68,"name":75,"description":76,"armGroupLabels":77,"otherNames":78},"Sacituzumab tirumotecan","Administered as an IV infusion",[50,63],[79,80,81],"sac-TMT","MK-2870","SKB264",{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":41},"DRUG","Histamine H1 Receptor Antagonist","Administered as a premedication per the approved product label",[50,63],{"type":83,"name":88,"description":85,"armGroupLabels":89,"otherNames":41},"Histamine H2 Receptor Antagonist",[50,63],{"type":83,"name":91,"description":85,"armGroupLabels":92,"otherNames":41},"Acetaminophen (or equivalent)",[50,63],{"type":83,"name":94,"description":85,"armGroupLabels":95,"otherNames":41},"Dexamethasone (or equivalent)",[50,63],{"type":83,"name":97,"description":98,"armGroupLabels":99,"otherNames":41},"Steroid mouthwash (dexamethasone or equivalent)","Administered orally per the approved product label as a rescue medication",[50,63],{"type":83,"name":101,"description":102,"armGroupLabels":103,"otherNames":41},"Epinephrine","Administered for emergency use per the approved product label",[50,63],[105],{"name":106,"affiliation":5,"role":107},"Medical Director","STUDY_DIRECTOR",[109],{"name":110,"role":111,"phone":112,"phoneExt":41,"email":113},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[115,133,145,160],{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"START San Antonio ( Site 0220)","RECRUITING","San Antonio","Texas","78229","United States","US",{"type":124,"coordinates":125},"Point",[126,127],-98.49363,29.42412,{"lat":127,"lon":126},[130],{"name":131,"role":111,"phone":132,"phoneExt":41,"email":41},"Study Coordinator","210-593-5265",{"facility":134,"status":117,"city":135,"state":41,"zip":41,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Queen Mary Hospital ( Site 2300)","Hong Kong","HK",{"type":124,"coordinates":138},[139,140],114.17469,22.27832,{"lat":140,"lon":139},[143],{"name":131,"role":111,"phone":144,"phoneExt":41,"email":41},"39103339",{"facility":146,"status":117,"city":147,"state":148,"zip":149,"country":150,"countryCode":151,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Ospedale Regionale Bellinzona e Valli ( Site 1102)","Bellinzona","Canton Ticino","6500","Switzerland","CH",{"type":124,"coordinates":153},[154,155],9.01703,46.19278,{"lat":155,"lon":154},[158],{"name":131,"role":111,"phone":159,"phoneExt":41,"email":41},"+41918119111",{"facility":161,"status":117,"city":162,"state":41,"zip":163,"country":150,"countryCode":151,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Cantonal Hospital St.Gallen ( Site 1100)","Sankt Gallen","9007",{"type":124,"coordinates":165},[166,167],9.37477,47.42391,{"lat":167,"lon":166},[170],{"name":131,"role":111,"phone":171,"phoneExt":41,"email":41},"+41714941111",{"type":173,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100653224","phase-2-a-clinical-trial-of-mk-2010-with-sacituzumab-tirumotecan-sac-tmt-in-participants-with-solid-tumors-mk-2010-100653224",false,"NCT07785609","A Clinical Trial of MK-2010 With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Solid Tumors (MK-2010)","Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of MK-2010 in Combination With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART)\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks\n* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load\n* Has adequate organ function\n\nExclusion Criteria:\n\n* If prior anticancer therapy is allowed, participants are excluded if they received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before allocation\n* Has received prior locoregional therapy within 2 weeks of start of study intervention, or has ongoing locoregional treatment-related toxicities\n* Is currently receiving any anticoagulants\n* Was discontinued from prior immunotherapy due to a Grade ≥3 immune-related adverse event (irAE)\n* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\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\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments\n* Active or ongoing stomatitis and\u002For mucositis of any grade\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis\n* Has history of posterior reversible encephalopathy syndrome (PRES) or seizure disorder\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or from central venous access device placement, or has ongoing surgical complications\n* Has clinically significant hemoptysis, hematemesis, or tumor bleeding within 4 weeks before the first dose of study intervention\n* Has any clinically significant or life-threatening bleeding event that occurred within 3 months prior to the first dose of the study intervention\n* Has pleural effusion, ascites, and\u002For pericardial effusion that are symptomatic or require repeated drainage\n* Has any history of myocarditis or cardiomyopathy\n* Has a current or history of severe cardiovascular and cerebrovascular diseases","ALL","18 Years",{"count":184,"type":185},200,"ESTIMATED","INTERVENTIONAL",[188],"PHASE2","Researchers are looking for new ways to treat certain types of advanced solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced may mean the cancer has spread to nearby or other parts of the body. The cancer may not be able to be treated with surgery or radiation, which uses beams of intense energy (like X-rays) to shrink or get rid of tumors. Some cancers may not have gone away or came back after previous treatment. MK-2010, the trial treatment, is designed to help the immune system fight cancer.\n\nThis trial will look at MK-2010 when given with another trial treatment called sacituzumab tirumotecan (sac-TMT). Sac-TMT is an antibody-drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.\n\nThe goals of this trial are to learn:\n\n* About the safety of MK-2010 with sac-TMT and if participants tolerate them. Tolerate means participants will receive trial treatment unless they need to stop it due to health problems.\n* How many participants who receive MK-2010 with sac-TMT have the cancer respond to treatment. Respond means the cancer gets smaller or goes away.",[191,192],"Advanced Solid Tumors","Malignant Neoplasm","2026-10-06",{"date":195,"type":196},"2026-10-09","ACTUAL",{"date":195,"type":185},{"date":199,"type":185},"2031-09-30",{"name":5,"class":6},4]