[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524386":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":11,"centralContacts":31,"locations":37,"responsibleParty":139,"collaborators":141,"id":144,"slug":145,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":11,"eligibilityCriteria":150,"healthyVolunteers":146,"sex":151,"minAge":152,"maxAge":11,"enrollmentInfo":153,"targetDuration":11,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Jazz Pharmaceuticals","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A1 Dose Exploration: JZP898 monotherapy","EXPERIMENTAL",null,[13],"Drug: JZP898",{"label":15,"type":10,"description":11,"interventionNames":16},"Part A2 Dose Exploration: JZP898 in combination with pembrolizumab",[13,17],"Drug: Pembrolizumab",{"label":19,"type":10,"description":11,"interventionNames":20},"Part B Combination Expansion: JZP898 in combination with pembrolizumab",[13,17],[22,27],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DRUG","JZP898","Investigational drug monotherapy",[9,15,19],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Pembrolizumab","Anti-PD1 antibody",[15,19],[32],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},"Clinical Trial Disclosure & Transparency","CONTACT","215-832-3750","ClinicalTrialDisclosure@JazzPharma.com",[38,52,60,70,80,90,100,110,120,129],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":11},"California Cancer Associates for Research and Excellence","RECRUITING","Encinitas","California","92024","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-117.29198,33.03699,{"lat":50,"lon":49},{"facility":39,"status":40,"city":53,"state":42,"zip":54,"country":44,"countryCode":45,"cosmosGeoPoint":55,"geoPoint":59,"contacts":11},"Fresno","93270",{"type":47,"coordinates":56},[57,58],-119.77237,36.74773,{"lat":58,"lon":57},{"facility":61,"status":40,"city":62,"state":63,"zip":64,"country":44,"countryCode":45,"cosmosGeoPoint":65,"geoPoint":69,"contacts":11},"Sarah Cannon Research Institute at HealthONE","Denver","Colorado","80218",{"type":47,"coordinates":66},[67,68],-104.9847,39.73915,{"lat":68,"lon":67},{"facility":71,"status":40,"city":72,"state":73,"zip":74,"country":44,"countryCode":45,"cosmosGeoPoint":75,"geoPoint":79,"contacts":11},"Florida Cancer Specialists","Orlando","Florida","32827",{"type":47,"coordinates":76},[77,78],-81.37924,28.53834,{"lat":78,"lon":77},{"facility":81,"status":40,"city":82,"state":83,"zip":84,"country":44,"countryCode":45,"cosmosGeoPoint":85,"geoPoint":89,"contacts":11},"Duke University Medical Center - Duke Cancer Institute","Durham","North Carolina","27710",{"type":47,"coordinates":86},[87,88],-78.89862,35.99403,{"lat":88,"lon":87},{"facility":91,"status":40,"city":92,"state":93,"zip":94,"country":44,"countryCode":45,"cosmosGeoPoint":95,"geoPoint":99,"contacts":11},"Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital","Philadelphia","Pennsylvania","19107",{"type":47,"coordinates":96},[97,98],-75.16362,39.95238,{"lat":98,"lon":97},{"facility":101,"status":40,"city":102,"state":103,"zip":104,"country":44,"countryCode":45,"cosmosGeoPoint":105,"geoPoint":109,"contacts":11},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":47,"coordinates":106},[107,108],-86.78444,36.16589,{"lat":108,"lon":107},{"facility":111,"status":40,"city":112,"state":113,"zip":114,"country":44,"countryCode":45,"cosmosGeoPoint":115,"geoPoint":119,"contacts":11},"Texas Oncology - Baylor Charles A Sammons Cancer Center","Dallas","Texas","75246",{"type":47,"coordinates":116},[117,118],-96.80667,32.78306,{"lat":118,"lon":117},{"facility":121,"status":40,"city":122,"state":113,"zip":123,"country":44,"countryCode":45,"cosmosGeoPoint":124,"geoPoint":128,"contacts":11},"The University of Texas MD Anderson Cancer Center","Houston","77030",{"type":47,"coordinates":125},[126,127],-95.36327,29.76328,{"lat":127,"lon":126},{"facility":130,"status":40,"city":131,"state":132,"zip":133,"country":44,"countryCode":45,"cosmosGeoPoint":134,"geoPoint":138,"contacts":11},"Virginia Cancer Specialists","Fairfax","Virginia","22031",{"type":47,"coordinates":135},[136,137],-77.30637,38.84622,{"lat":137,"lon":136},{"type":140,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[142],{"name":143,"class":6},"Merck Sharp & Dohme LLC","100524386","phase-1-jzp898-intravenous-infusion-as-monotherapy-and-combination-with-pembrolizumab-in-adults-with-advancedmetastatic-solid-tumors-100524386",false,"NCT06108050","JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-human, Open-label, Multicenter Study of JZP898 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\n* Adult ≥ 18 years of age\n* Histological or cytological diagnosis of advanced or metastatic solid tumor.\n\n  1. Previously treated participants with solid tumors that are amenable to CPI therapy (eg. NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal carcinomas, UC, or CRC \\[MSI-H\\]) for whom, in the opinion of the investigator, there is no SoC available to convey clinical benefit.\n  2. Parts A2 and B: previously-treated (≥ 1 line of prior anticancer therapy) participants with select tumor types (NSCLC, HNSCC, melanomas, RCC, and UC) who have progressed on\u002Fafter prior CPI therapy based on investigator assessment per RECIST version 1.1.\n* Participants in select tumor types:\n\n  1. NSCLC: eligible for platinum-based therapy and received platinum-based therapy prior to inclusion in the study.\n  2. HNSCC: eligible for platinum therapy and received platinum-based therapy prior to inclusion in this study.\n  3. Melanoma with known BRAFv600 mutation: received BRAF\u002FMEKi therapy before this study.\n* ECOG score of 0 to 1.\n* Measurable disease per RECIST version 1.1 criteria.\n* Parts A1 and A2 only: willing to consent to mandatory tumor biopsies (both pretreatment and post-treatment with JZP898) unless medically infeasible\n* Adequate organ and bone marrow function as indicated by the following laboratory values (within 4 weeks prior to starting the study interventions)\n* Men and women of reproductive potential to observe highly effective birth control for the duration of treatment and for 4 months following the last dose of study drug;\n* Additional criteria may apply\n\nExclusion Criteria\n\n* Unresolved toxicities from previous therapy that is \\> Grade 1.\n* Hypersensitivity to mAb, IFNα, or study intervention components.\n* Primary CNS tumor or symptomatic CNS metastases.\n* Have a second primary malignancy treated within the previous 2 years (exceptions: non-metastatic, non-melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ).\n* Active autoimmune disease (in the last 2 years) requiring systemic steroids or immunosuppressive agents.\n* Active or history of pneumonitis (noninfectious) or interstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Any history of suicidal behavior or any suicidal ideation\n* Clinically significant ischemic\u002Fhemorrhagic cerebrovascular accident\u002Fstroke and\u002For clinically significant active cardiovascular disease\n* Received any anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug\n* Received prior radiotherapy within 2 weeks of the first dose of study drug or have had a history of radiation pneumonitis\n* Major surgery within 2 weeks prior to the first dose of study intervention.\n* Participant is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study\n* Had a stem cell\u002Fsolid organ transplant.\n* Receipt of prior IFNα therapy","ALL","18 Years",{"count":154,"type":155},177,"ESTIMATED","INTERVENTIONAL",[158],"PHASE1","This Phase 1 first-in-human study will investigate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of JZP898 monotherapy as well as JZP898 in combination with pembrolizumab in adult participants with advanced or metastatic solid tumors.",[161,162],"Advanced Solid Tumor","Metastatic Solid Tumor",[161,162,24],"2025-12-08",{"date":166,"type":167},"2025-12-16","ACTUAL",{"date":169,"type":167},"2023-11-07",{"date":171,"type":155},"2028-05-31",{"name":5,"class":6},10]