[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446799":3},{"organization":4,"outcomesModule":7,"designInfo":93,"detailedDescription":99,"studyPopulation":92,"armGroups":100,"interventions":143,"overallOfficials":92,"centralContacts":160,"locations":166,"responsibleParty":588,"collaborators":590,"id":593,"slug":594,"hasResults":595,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":595,"sex":601,"minAge":602,"maxAge":92,"enrollmentInfo":603,"targetDuration":92,"studyType":606,"phases":607,"briefSummary":610,"conditions":611,"keywords":92,"overallStatus":169,"whyStopped":92,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":625},{"fullName":5,"class":6},"Synthekine","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":37,"otherOutcomes":92},[9,13,16,20,24,27,30,33],{"measure":10,"description":11,"timeFrame":12},"Phase 1a: Treatment emergent adverse events (TEAEs)","Incidence of TEAEs in participants with select advanced solid tumors","From 1st dose of study treatment through 90 days after last dose",{"measure":14,"description":15,"timeFrame":12},"Phase 1a: Serious adverse events (SAEs)","Incidence of SAEs in participants with select advanced solid tumors",{"measure":17,"description":18,"timeFrame":19},"Phase 1a: Dose limiting toxicities (DLTs)","Incidence of DLTs in participants with select advanced solid tumors","Cycle 1, Days 1 through 21",{"measure":21,"description":22,"timeFrame":23},"Phase 1a: Deaths","Incidence of death in participants with select advanced solid tumors","From 1st dose of study treatment until death, up to 4 years",{"measure":25,"description":26,"timeFrame":12},"Phase 1b: TEAEs at the RP2D","Incidence of TEAEs at the recommended phase 2 dose (RP2D) in participants with select advanced solid tumors",{"measure":28,"description":29,"timeFrame":12},"Phase 1b: SAEs at the RP2D","Incidence of SAEs at the RP2D in participants with select advanced solid tumors",{"measure":31,"description":32,"timeFrame":23},"Phase 1b: Deaths at the RP2D","Incidence of death at the RP2D in participants with select advanced solid tumors",{"measure":34,"description":35,"timeFrame":36},"Phase 2: Overall response rate (ORR) in Arm A versus Arm C","To compare the ORR in 1L NSQ NSCLC (PD-L1\\\u003C1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per BICR.","From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years",[38,42,46,50,54,57,60,63,66,70,73,76,80,83,86,89],{"measure":39,"description":40,"timeFrame":41},"Phase 1: ORR","Assessment of preliminary efficacy, specifically ORR, in select advanced solid tumors. ORR is the proportion of subjects with confirmed CR or confirmed PR per investigator assessment.","From enrollment until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years",{"measure":43,"description":44,"timeFrame":45},"Phase 1: Progression free survival (PFS)","Assessment of preliminary efficacy, specifically PFS, in select advanced solid tumors.","From enrollment until first documentation of disease progression per investigator assessment or death due to any cause, whichever occurs first, up to 4 years",{"measure":47,"description":48,"timeFrame":49},"Phase 1: Overall survival (OS)","Assessment of preliminary efficacy, specifically OS, in select advanced solid tumors.","From enrollment until death due to any cause, up to 4 years",{"measure":51,"description":52,"timeFrame":53},"Phase 1\u002F2: STK-012 ADAs","Anti-drug antibodies (ADA) to assess immunogenicity of STK-012 in advanced NSCLC and other select solid tumors.","From screening through 30 days after last dose of STK-012",{"measure":55,"description":56,"timeFrame":53},"Phase 1\u002F2: AUC of STK-012","Area under the curve (AUC) to assess pharmacokinetic (PK) characterization of STK-012 in advanced NSCLC and other select solid tumors.",{"measure":58,"description":59,"timeFrame":53},"Phase 1\u002F2: Cmax of STK-012","Maximum concentration (Cmax) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors.",{"measure":61,"description":62,"timeFrame":53},"Phase 1\u002F2: Tmax of STK-012","Time of maximum concentration (Tmax) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors.",{"measure":64,"description":65,"timeFrame":53},"Phase 1\u002F2: Half life of STK-012","Half life (t1\u002F2) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors.",{"measure":67,"description":68,"timeFrame":69},"Phase 2: PFS in Arm A versus Arm C","To compare the PFS in 1L NSQ NSCLC (PD-L1\\\u003C1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.","From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years",{"measure":71,"description":72,"timeFrame":36},"Phase 2: ORR in Arm B versus Arm C","To compare the ORR in 1L NSQ NSCLC (PD-L1\\\u003C1% or STK11m) subjects treated with STK-012 1.5 mg + SoC vs. SoC (Arms B vs. C). ORR is the proportion of subjects with confirmed CR or confirmed PR per BICR.",{"measure":74,"description":75,"timeFrame":69},"Phase 2: PFS in Arm B versus Arm C","To compare the PFS in 1L NSQ NSCLC (PD-L1\\\u003C1% or STK11m) subjects treated with STK-012 1.5 mg + SoC vs. SoC (Arms B vs. C). PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.",{"measure":77,"description":78,"timeFrame":79},"Phase 2: OS in Arm A versus C","To compare the OS in 1L NSQ NSCLC (PD-L1\\\u003C1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). OS is the time from randomization until death due to any cause.","From randomization until death due to any cause, up to 4 years",{"measure":81,"description":82,"timeFrame":79},"Phase 2: OS in Arm B versus C","To compare the OS in 1L NSQ NSCLC (PD-L1\\\u003C1% or STK11m) subjects treated with STK-012 1.5 mg + SoC vs. SoC (Arms B vs. C). OS is the time from randomization until death due to any cause.",{"measure":84,"description":85,"timeFrame":12},"Phase 2: TEAEs","Incidence of TEAEs in 1L NSQ NSCLC (PD-L1\\\u003C1% or STK11m)",{"measure":87,"description":88,"timeFrame":12},"Phase 2: SAEs","Incidence of SAEs in 1L NSQ NSCLC (PD-L1\\\u003C1% or STK11m)",{"measure":90,"description":91,"timeFrame":23},"Phase 2: Deaths","Incidence of death in 1L NSQ NSCLC (PD-L1\\\u003C1% or STK11m)",null,{"allocation":94,"interventionModel":95,"interventionModelDescription":92,"primaryPurpose":96,"observationalModel":92,"timePerspective":92,"maskingInfo":97},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":98,"maskingDescription":92,"whoMasked":92},"NONE","Phase 1: The phase 1a portion is a dose escalation study to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion is a dose expansion study to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.\n\nPhase 2: The phase 2 portion is a randomized, open label study to evaluate STK-012 at two dose levels in combination with standard of care (SoC) pembrolizumab, pemetrexed and carboplatin, versus SoC, in patients with first line, PD-L1 negative or STK11 mutated, non-squamous, non-small cell lung cancer. Subjects in the randomized Phase 2 portion (Part G) will be randomized 1:1:1 and stratified by tumor PD-L1 expression and STK11 mutation status.",[101,107,112,118,122,126,130,134,138],{"label":102,"type":103,"description":104,"interventionNames":105},"Phase 1a: STK-012 monotherapy dose escalation","EXPERIMENTAL","STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications",[106],"Drug: STK-012",{"label":108,"type":103,"description":109,"interventionNames":110},"Phase 1a: STK-012 + pembrolizumab dose escalation","STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications",[106,111],"Drug: pembrolizumab KEYTRUDA®",{"label":113,"type":103,"description":114,"interventionNames":115},"Phase 1a: STK-012 + standard of care (SoC) dose escalation","STK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC",[106,111,116,117],"Drug: pemetrexed","Drug: carboplatin",{"label":119,"type":103,"description":120,"interventionNames":121},"Phase 1b: STK-012 monotherapy expansion","STK-012 SC monotherapy in selected solid tumor indications",[106],{"label":123,"type":103,"description":124,"interventionNames":125},"Phase 1b: STK-012 + pembrolizumab dose expansion","STK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications",[106,111],{"label":127,"type":103,"description":128,"interventionNames":129},"Phase 1b: STK-012 + SoC dose expansion","STK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC",[106,111,116,117],{"label":131,"type":103,"description":132,"interventionNames":133},"Phase 2: Arm A","STK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC",[106,111,116,117],{"label":135,"type":103,"description":136,"interventionNames":137},"Phase 2: Arm B","STK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC",[106,111,116,117],{"label":139,"type":140,"description":141,"interventionNames":142},"Phase 2: Arm C","ACTIVE_COMPARATOR","SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC",[111,116,117],[144,149,153,157],{"type":145,"name":146,"description":147,"armGroupLabels":148,"otherNames":92},"DRUG","STK-012","Engineered Interleukin-2 (IL-2) selective for antigen activated T cells",[108,113,102,127,123,119,131,135],{"type":145,"name":150,"description":151,"armGroupLabels":152,"otherNames":92},"pembrolizumab KEYTRUDA®","anti-PD-1 monoclonal antibody",[108,113,127,123,131,135,139],{"type":145,"name":154,"description":155,"armGroupLabels":156,"otherNames":92},"pemetrexed","chemotherapy",[113,127,131,135,139],{"type":145,"name":158,"description":155,"armGroupLabels":159,"otherNames":92},"carboplatin",[113,127,131,135,139],[161],{"name":162,"role":163,"phone":164,"phoneExt":92,"email":165},"Synthekine STK-012-101 Contact","CONTACT","650-606-6319","STK-012-101.contact@synthekine.com",[167,181,191,200,210,219,228,237,247,257,267,277,287,297,303,308,318,328,336,342,348,358,368,377,387,397,407,417,426,437,446,454,464,474,484,493,498,503,514,520,526,535,546,555,564,570,579],{"facility":168,"status":169,"city":170,"state":171,"zip":172,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":180,"contacts":92},"University of Arizona Cancer Center","RECRUITING","Tucson","Arizona","85721","United States","US",{"type":176,"coordinates":177},"Point",[178,179],-110.92648,32.22174,{"lat":179,"lon":178},{"facility":182,"status":169,"city":183,"state":184,"zip":185,"country":173,"countryCode":174,"cosmosGeoPoint":186,"geoPoint":190,"contacts":92},"Beverly Hills Cancer Center","Beverly Hills","California","90211",{"type":176,"coordinates":187},[188,189],-118.40036,34.07362,{"lat":189,"lon":188},{"facility":192,"status":169,"city":193,"state":184,"zip":194,"country":173,"countryCode":174,"cosmosGeoPoint":195,"geoPoint":199,"contacts":92},"Providence Medical Foundation","Fullerton","92835",{"type":176,"coordinates":196},[197,198],-117.92534,33.87029,{"lat":198,"lon":197},{"facility":201,"status":202,"city":203,"state":184,"zip":204,"country":173,"countryCode":174,"cosmosGeoPoint":205,"geoPoint":209,"contacts":92},"UC San Diego Moores Cancer Center","ACTIVE_NOT_RECRUITING","La Jolla","92093-0698",{"type":176,"coordinates":206},[207,208],-117.2742,32.84727,{"lat":208,"lon":207},{"facility":211,"status":169,"city":212,"state":184,"zip":213,"country":173,"countryCode":174,"cosmosGeoPoint":214,"geoPoint":218,"contacts":92},"Cedars Sinai","Los Angeles","90048",{"type":176,"coordinates":215},[216,217],-118.24368,34.05223,{"lat":217,"lon":216},{"facility":220,"status":169,"city":221,"state":184,"zip":222,"country":173,"countryCode":174,"cosmosGeoPoint":223,"geoPoint":227,"contacts":92},"Hoag Memorial Hospital Presbyterian","Newport Beach","92663",{"type":176,"coordinates":224},[225,226],-117.92895,33.61891,{"lat":226,"lon":225},{"facility":229,"status":169,"city":230,"state":184,"zip":231,"country":173,"countryCode":174,"cosmosGeoPoint":232,"geoPoint":236,"contacts":92},"UCLA Hematology\u002FOncology - Santa Monica","Santa Monica","90404",{"type":176,"coordinates":233},[234,235],-118.49138,34.01949,{"lat":235,"lon":234},{"facility":238,"status":169,"city":239,"state":240,"zip":241,"country":173,"countryCode":174,"cosmosGeoPoint":242,"geoPoint":246,"contacts":92},"Yale New Haven Hospital, Yale Cancer Center","New Haven","Connecticut","06510",{"type":176,"coordinates":243},[244,245],-72.92816,41.30815,{"lat":245,"lon":244},{"facility":248,"status":169,"city":249,"state":250,"zip":251,"country":173,"countryCode":174,"cosmosGeoPoint":252,"geoPoint":256,"contacts":92},"Georgetown University","Washington D.C.","District of Columbia","20057",{"type":176,"coordinates":253},[254,255],-77.03637,38.89511,{"lat":255,"lon":254},{"facility":258,"status":169,"city":259,"state":260,"zip":261,"country":173,"countryCode":174,"cosmosGeoPoint":262,"geoPoint":266,"contacts":92},"Winship Cancer Institute, Emory University","Atlanta","Georgia","30322",{"type":176,"coordinates":263},[264,265],-84.38798,33.749,{"lat":265,"lon":264},{"facility":268,"status":169,"city":269,"state":270,"zip":271,"country":173,"countryCode":174,"cosmosGeoPoint":272,"geoPoint":276,"contacts":92},"University of Chicago","Chicago","Illinois","60637",{"type":176,"coordinates":273},[274,275],-87.65005,41.85003,{"lat":275,"lon":274},{"facility":278,"status":169,"city":279,"state":280,"zip":281,"country":173,"countryCode":174,"cosmosGeoPoint":282,"geoPoint":286,"contacts":92},"University of Maryland","Baltimore","Maryland","21201",{"type":176,"coordinates":283},[284,285],-76.61219,39.29038,{"lat":285,"lon":284},{"facility":288,"status":169,"city":289,"state":290,"zip":291,"country":173,"countryCode":174,"cosmosGeoPoint":292,"geoPoint":296,"contacts":92},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":176,"coordinates":293},[294,295],-71.05977,42.35843,{"lat":295,"lon":294},{"facility":298,"status":169,"city":289,"state":290,"zip":299,"country":173,"countryCode":174,"cosmosGeoPoint":300,"geoPoint":302,"contacts":92},"Beth Israel Deaconess Medical Center","02215",{"type":176,"coordinates":301},[294,295],{"lat":295,"lon":294},{"facility":304,"status":169,"city":289,"state":290,"zip":299,"country":173,"countryCode":174,"cosmosGeoPoint":305,"geoPoint":307,"contacts":92},"Dana-Farber Cancer Institute",{"type":176,"coordinates":306},[294,295],{"lat":295,"lon":294},{"facility":309,"status":169,"city":310,"state":311,"zip":312,"country":173,"countryCode":174,"cosmosGeoPoint":313,"geoPoint":317,"contacts":92},"HealthPartners Cancer Center at Regions Hospital","Saint Paul","Minnesota","55101",{"type":176,"coordinates":314},[315,316],-93.09327,44.94441,{"lat":316,"lon":315},{"facility":319,"status":169,"city":320,"state":321,"zip":322,"country":173,"countryCode":174,"cosmosGeoPoint":323,"geoPoint":327,"contacts":92},"Northwell Health","Lake Success","New York","11042",{"type":176,"coordinates":324},[325,326],-73.71763,40.77066,{"lat":326,"lon":325},{"facility":329,"status":169,"city":321,"state":321,"zip":330,"country":173,"countryCode":174,"cosmosGeoPoint":331,"geoPoint":335,"contacts":92},"NYU Langone Health","10016",{"type":176,"coordinates":332},[333,334],-74.00597,40.71427,{"lat":334,"lon":333},{"facility":337,"status":202,"city":321,"state":321,"zip":338,"country":173,"countryCode":174,"cosmosGeoPoint":339,"geoPoint":341,"contacts":92},"Columbia University Irving Medical Center","10032",{"type":176,"coordinates":340},[333,334],{"lat":334,"lon":333},{"facility":343,"status":169,"city":321,"state":321,"zip":344,"country":173,"countryCode":174,"cosmosGeoPoint":345,"geoPoint":347,"contacts":92},"Memorial Sloan-Kettering Cancer Center","10065",{"type":176,"coordinates":346},[333,334],{"lat":334,"lon":333},{"facility":349,"status":202,"city":350,"state":351,"zip":352,"country":173,"countryCode":174,"cosmosGeoPoint":353,"geoPoint":357,"contacts":92},"Duke Cancer Center","Durham","North Carolina","27710",{"type":176,"coordinates":354},[355,356],-78.89862,35.99403,{"lat":356,"lon":355},{"facility":359,"status":169,"city":360,"state":361,"zip":362,"country":173,"countryCode":174,"cosmosGeoPoint":363,"geoPoint":367,"contacts":92},"University Hospitals Cleveland","Cleveland","Ohio","44106",{"type":176,"coordinates":364},[365,366],-81.69541,41.4995,{"lat":366,"lon":365},{"facility":369,"status":169,"city":370,"state":361,"zip":371,"country":173,"countryCode":174,"cosmosGeoPoint":372,"geoPoint":376,"contacts":92},"The James Cancer Hospital and Solove Research Institute","Columbus","43210",{"type":176,"coordinates":373},[374,375],-82.99879,39.96118,{"lat":375,"lon":374},{"facility":378,"status":169,"city":379,"state":380,"zip":381,"country":173,"countryCode":174,"cosmosGeoPoint":382,"geoPoint":386,"contacts":92},"Providence Cancer Institute","Portland","Oregon","97123",{"type":176,"coordinates":383},[384,385],-122.67621,45.52345,{"lat":385,"lon":384},{"facility":388,"status":169,"city":389,"state":390,"zip":391,"country":173,"countryCode":174,"cosmosGeoPoint":392,"geoPoint":396,"contacts":92},"Fox Chase Cancer Center","Philadelphia","Pennsylvania","19111",{"type":176,"coordinates":393},[394,395],-75.16362,39.95238,{"lat":395,"lon":394},{"facility":398,"status":399,"city":400,"state":390,"zip":401,"country":173,"countryCode":174,"cosmosGeoPoint":402,"geoPoint":406,"contacts":92},"UPMC Hillman Cancer Center","TERMINATED","Pittsburgh","15232",{"type":176,"coordinates":403},[404,405],-79.99589,40.44062,{"lat":405,"lon":404},{"facility":408,"status":202,"city":409,"state":410,"zip":411,"country":173,"countryCode":174,"cosmosGeoPoint":412,"geoPoint":416,"contacts":92},"Baptist Memorial Hospital Cancer Center","Memphis","Tennessee","38120",{"type":176,"coordinates":413},[414,415],-90.04898,35.14953,{"lat":415,"lon":414},{"facility":418,"status":202,"city":419,"state":410,"zip":420,"country":173,"countryCode":174,"cosmosGeoPoint":421,"geoPoint":425,"contacts":92},"Sarah Cannon Research Institute - Nashville","Nashville","37203",{"type":176,"coordinates":422},[423,424],-86.78444,36.16589,{"lat":424,"lon":423},{"facility":427,"status":428,"city":429,"state":430,"zip":431,"country":173,"countryCode":174,"cosmosGeoPoint":432,"geoPoint":436,"contacts":92},"Renovatio Clinical","WITHDRAWN","El Paso","Texas","79915",{"type":176,"coordinates":433},[434,435],-106.48693,31.75872,{"lat":435,"lon":434},{"facility":438,"status":169,"city":439,"state":430,"zip":440,"country":173,"countryCode":174,"cosmosGeoPoint":441,"geoPoint":445,"contacts":92},"Oncology Consultants","Houston","77303",{"type":176,"coordinates":442},[443,444],-95.36327,29.76328,{"lat":444,"lon":443},{"facility":427,"status":428,"city":447,"state":430,"zip":448,"country":173,"countryCode":174,"cosmosGeoPoint":449,"geoPoint":453,"contacts":92},"The Woodlands","77380",{"type":176,"coordinates":450},[451,452],-95.48938,30.15799,{"lat":452,"lon":451},{"facility":455,"status":169,"city":456,"state":457,"zip":458,"country":173,"countryCode":174,"cosmosGeoPoint":459,"geoPoint":463,"contacts":92},"NEXT Virginia","Fairfax","Virginia","22031",{"type":176,"coordinates":460},[461,462],-77.30637,38.84622,{"lat":462,"lon":461},{"facility":465,"status":202,"city":466,"state":467,"zip":468,"country":173,"countryCode":174,"cosmosGeoPoint":469,"geoPoint":473,"contacts":92},"Northwest Medical Specialties","Tacoma","Washington","98405",{"type":176,"coordinates":470},[471,472],-122.44429,47.25288,{"lat":472,"lon":471},{"facility":475,"status":169,"city":476,"state":92,"zip":477,"country":260,"countryCode":478,"cosmosGeoPoint":479,"geoPoint":483,"contacts":92},"LTD High Technology Hospital Medcenter","Batumi","6000","GE",{"type":176,"coordinates":480},[481,482],41.6306,41.64077,{"lat":482,"lon":481},{"facility":485,"status":169,"city":486,"state":92,"zip":487,"country":260,"countryCode":478,"cosmosGeoPoint":488,"geoPoint":492,"contacts":92},"Caraps Medline, Ltd (JSC VIAN)","Tbilisi","0159",{"type":176,"coordinates":489},[490,491],44.83412,41.69143,{"lat":491,"lon":490},{"facility":494,"status":169,"city":486,"state":92,"zip":487,"country":260,"countryCode":478,"cosmosGeoPoint":495,"geoPoint":497,"contacts":92},"Institute of Clinical Oncology (ICO)",{"type":176,"coordinates":496},[490,491],{"lat":491,"lon":490},{"facility":499,"status":169,"city":486,"state":92,"zip":487,"country":260,"countryCode":478,"cosmosGeoPoint":500,"geoPoint":502,"contacts":92},"Israel Georgian Medical Research Clinic Healthycore",{"type":176,"coordinates":501},[490,491],{"lat":491,"lon":490},{"facility":504,"status":169,"city":505,"state":92,"zip":506,"country":507,"countryCode":508,"cosmosGeoPoint":509,"geoPoint":513,"contacts":92},"START Dublin","Dublin","07","Ireland","IE",{"type":176,"coordinates":510},[511,512],-6.24889,53.33306,{"lat":512,"lon":511},{"facility":515,"status":169,"city":505,"state":92,"zip":516,"country":507,"countryCode":508,"cosmosGeoPoint":517,"geoPoint":519,"contacts":92},"St. James Hospital","08",{"type":176,"coordinates":518},[511,512],{"lat":512,"lon":511},{"facility":521,"status":169,"city":505,"state":92,"zip":522,"country":507,"countryCode":508,"cosmosGeoPoint":523,"geoPoint":525,"contacts":92},"Beaumont Hospital","09",{"type":176,"coordinates":524},[511,512],{"lat":512,"lon":511},{"facility":527,"status":169,"city":528,"state":92,"zip":529,"country":507,"countryCode":508,"cosmosGeoPoint":530,"geoPoint":534,"contacts":92},"University Hospital Galway","Galway","H91 YR71",{"type":176,"coordinates":531},[532,533],-9.05095,53.27245,{"lat":533,"lon":532},{"facility":536,"status":169,"city":537,"state":92,"zip":538,"country":539,"countryCode":540,"cosmosGeoPoint":541,"geoPoint":545,"contacts":92},"Hospital Quirón Barcelona","Barcelona","08023","Spain","ES",{"type":176,"coordinates":542},[543,544],2.15899,41.38879,{"lat":544,"lon":543},{"facility":547,"status":169,"city":548,"state":92,"zip":549,"country":539,"countryCode":540,"cosmosGeoPoint":550,"geoPoint":554,"contacts":92},"START Rioja","Logroño","26006",{"type":176,"coordinates":551},[552,553],-2.45115,42.46615,{"lat":553,"lon":552},{"facility":556,"status":169,"city":557,"state":92,"zip":558,"country":539,"countryCode":540,"cosmosGeoPoint":559,"geoPoint":563,"contacts":92},"MD Anderson","Madrid","28033",{"type":176,"coordinates":560},[561,562],-3.70256,40.4165,{"lat":562,"lon":561},{"facility":565,"status":169,"city":557,"state":92,"zip":566,"country":539,"countryCode":540,"cosmosGeoPoint":567,"geoPoint":569,"contacts":92},"Hospital Universitario Ramon y Cajal","28034",{"type":176,"coordinates":568},[561,562],{"lat":562,"lon":561},{"facility":571,"status":169,"city":572,"state":92,"zip":573,"country":539,"countryCode":540,"cosmosGeoPoint":574,"geoPoint":578,"contacts":92},"Hospital Regional de Málaga","Málaga","29011",{"type":176,"coordinates":575},[576,577],-4.42034,36.72016,{"lat":577,"lon":576},{"facility":580,"status":169,"city":581,"state":92,"zip":582,"country":539,"countryCode":540,"cosmosGeoPoint":583,"geoPoint":587,"contacts":92},"Clinica Universidad de Navarra - Pamplona","Pamplona","31008",{"type":176,"coordinates":584},[585,586],-1.64323,42.81687,{"lat":586,"lon":585},{"type":589,"investigatorFullName":92,"investigatorTitle":92,"investigatorAffiliation":92,"oldNameTitle":92,"oldOrganization":92},"SPONSOR",[591],{"name":592,"class":6},"Merck Sharp & Dohme LLC","100446799","phase-1-study-of-stk-012-alone-and-with-other-treatments-in-patients-with-advanced-lung-cancer-and-other-cancers-100446799",false,"NCT05098132","Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers","A Phase 1\u002F2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects With Front-line Advanced NSCLC and Other Selected Indications","SYNERGY-101","Selected Inclusion Criteria:\n\n1. Phase 1: Selected advanced solid tumors\n2. Phase 2:\n\n   * Diagnosis of non-small cell lung cancer (NSCLC).\n   * Stage IV or Stage IIIB\u002FIIIC and not a candidate for definitive treatment.\n   * Non-squamous (NSQ) cell histology.\n   * No prior systemic therapy for advanced\u002Fmetastatic NSQ NSCLC.\n   * Must have a tumor that meets at least one of the following criteria on local testing:\n\n     * PD-L1 negative (TPS \\\u003C1%), OR;\n     * STK11 mutated on tumor tissue or ctDNA\n   * No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.\n\nSelected Exclusion Criteria:\n\n2\\. Phase 2:\n\n* Prior immune checkpoint inhibitor (anti-PD\\[L\\]1 and\u002For anti-CTLA-4) treatment\n* Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).\n* Received radiotherapy ≤ 7 days of the first dose of study treatment.\n* Known active central nervous system metastases\n* Any history of carcinomatous meningitis","ALL","18 Years",{"count":604,"type":605},364,"ESTIMATED","INTERVENTIONAL",[608,609],"PHASE1","PHASE2","This is a phase 1\u002F2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative or STK11 mutated, non-squamous, non-small cell lung cancer.",[612,613,614,615],"Advanced Solid Tumor","Non Small Cell Lung Cancer","Untreated Advanced NSCLC","1st Line NSCLC","2026-06-24",{"date":618,"type":619},"2026-06-29","ACTUAL",{"date":621,"type":619},"2022-01-25",{"date":623,"type":605},"2029-01",{"name":5,"class":6},47]