[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601187":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":107,"collaborators":19,"id":109,"slug":19,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":19,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":19,"enrollmentInfo":117,"targetDuration":19,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"JNJ-95437446","EXPERIMENTAL","Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1.",[13],"Drug: JNJ-95437446",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","JNJ-95437446 will be administered.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[27,40,50,60,70,76,86,95,101],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":19},"Florida Cancer Specialists","RECRUITING","Sarasota","Florida","34232","United States",{"type":35,"coordinates":36},"Point",[37,38],-82.53065,27.33643,{"lat":38,"lon":37},{"facility":41,"status":29,"city":42,"state":43,"zip":44,"country":33,"cosmosGeoPoint":45,"geoPoint":49,"contacts":19},"Tennessee Oncology","Nashville","Tennessee","37203",{"type":35,"coordinates":46},[47,48],-86.78444,36.16589,{"lat":48,"lon":47},{"facility":51,"status":29,"city":52,"state":53,"zip":54,"country":33,"cosmosGeoPoint":55,"geoPoint":59,"contacts":19},"NEXT Oncology","Fairfax","Virginia","22031",{"type":35,"coordinates":56},[57,58],-77.30637,38.84622,{"lat":58,"lon":57},{"facility":61,"status":29,"city":62,"state":19,"zip":63,"country":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":19},"Severance Hospital Yonsei University Health System","Seoul","03722","South Korea",{"type":35,"coordinates":66},[67,68],126.9784,37.566,{"lat":68,"lon":67},{"facility":71,"status":29,"city":62,"state":19,"zip":72,"country":64,"cosmosGeoPoint":73,"geoPoint":75,"contacts":19},"Samsung Medical Center","06351",{"type":35,"coordinates":74},[67,68],{"lat":68,"lon":67},{"facility":77,"status":29,"city":78,"state":19,"zip":79,"country":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":19},"Hosp Univ Vall D Hebron","Barcelona","8035","Spain",{"type":35,"coordinates":82},[83,84],2.15899,41.38879,{"lat":84,"lon":83},{"facility":87,"status":29,"city":88,"state":19,"zip":89,"country":80,"cosmosGeoPoint":90,"geoPoint":94,"contacts":19},"Hosp Univ Fund Jimenez Diaz","Madrid","28040",{"type":35,"coordinates":91},[92,93],-3.70256,40.4165,{"lat":93,"lon":92},{"facility":96,"status":29,"city":88,"state":19,"zip":97,"country":80,"cosmosGeoPoint":98,"geoPoint":100,"contacts":19},"Hosp. Univ. 12 de Octubre","28041",{"type":35,"coordinates":99},[92,93],{"lat":93,"lon":92},{"facility":102,"status":29,"city":88,"state":19,"zip":103,"country":80,"cosmosGeoPoint":104,"geoPoint":106,"contacts":19},"Hosp Univ Hm Sanchinarro","28050",{"type":35,"coordinates":105},[92,93],{"lat":93,"lon":92},{"type":108,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100601187",false,"NCT07107230","A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors","A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors","Inclusion Criteria:\n\n* Participants must have been previously diagnosed with histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma\n* Participants with non-small cell lung cancer (NSCLC) adenocarcinoma and colorectal cancer (CRC) must have local molecular testing to determine epidermal growth factor receptor (EGFR) mutational status for NSCLC and Kirsten rat sarcoma\u002Fneuroblastoma ras viral oncogene\u002Fv-raf murine sarcoma oncogene B1 (KRAS\u002FNRAS\u002FBRAF) mutation status for CRC\n* Have measurable or evaluable disease:\n* Part 1: Either measurable or evaluable disease; Part 2: At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version (v) 1.1\n* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening\n* Participants must have appropriate hematologic, renal, and hepatic function within the required limits\n\nExclusion Criteria:\n\n* Any prior medical history of ILD\u002Fpneumonitis, including pneumonitis from anti-PD-1\u002F PD-L1 antibody or radiation that required systemic steroids\n* Toxicity from prior anticancer therapy that has not resolved to Grade \\\u003C=1\n* Evidence of clinically significant active viral, bacterial, or fungal infection within 7 days before the first dose of study treatment requiring systemic or non-topical treatment\n* History of clinically significant cardiovascular disease within 6 months prior to signing informed consent\n* Participants with prior or concurrent second malignancy cannot be enrolled if prior\u002Fconcurrent malignancy's natural history of treatment is likely to interfere with any safety or efficacy study endpoints","ALL","18 Years",{"count":118,"type":119},380,"ESTIMATED","INTERVENTIONAL",[122],"PHASE1","The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.",[125],"Colorectal Neoplasms","2026-06-04",{"date":128,"type":129},"2026-06-05","ACTUAL",{"date":131,"type":129},"2025-07-15",{"date":133,"type":119},"2028-04-24",{"name":5,"class":6},9]