[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553012":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":47,"centralContacts":52,"locations":58,"responsibleParty":182,"collaborators":41,"id":184,"slug":41,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":41,"eligibilityCriteria":189,"healthyVolunteers":185,"sex":190,"minAge":191,"maxAge":41,"enrollmentInfo":192,"targetDuration":41,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":41,"overallStatus":61,"whyStopped":41,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},{"fullName":5,"class":6},"Teva Branded Pharmaceutical Products R&D, Inc.","INDUSTRY",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: TEV-56278 Monotherapy Dose Escalation","EXPERIMENTAL","Part 1 will be initiated first and will evaluate dose escalation of TEV-56278 as a monotherapy in selected solid tumors",[13],"Drug: TEV-56278",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2: Cohort A -TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Primary Resistance","Part 2 Cohort A will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in non-small cell lung carcinoma (NSCLC) (primary and secondary resistant to anti-PD-(L)1).\n\nEU participants will only be included in Part 2.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 2: Cohort B- TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Secondary Resistance","Part 2 Cohort B will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in NSCLC (primary and secondary resistant to anti-PD-(L)1)\n\nOnly Cohort B will be randomized",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part 2: Cohort C - TEV-56278 Monotherapy Dose Expansion in NSCLC Primary Resistance","Part 2 Cohort C will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in NSCLC (primary and secondary resistant to anti-PD-(L)1)",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Part 2: Cohort D - TEV-56278 Monotherapy Dose Expansion in NSCLC Secondary Resistance","Part 2 Cohort D will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in NSCLC (primary and secondary resistant to anti-PD-(L)1)",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Part 3: TEV-56278 and Pembrolizumab Combination Dose Escalation","Part 3 will be initiated at the discretion of the Sponsor, after some or all of the dose levels in Part 1 have been explored. Part 3 will evaluate escalating doses of TEV-56278 in combination with a fixed dose of pembrolizumab (400 mg Q6W) and include dose escalation in selected solid tumors (same indications as in Part 1)",[34],"Drug: Pembrolizumab",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","TEV-56278","Administered intravenously",[9,15,19,23,27],null,{"type":37,"name":43,"description":39,"armGroupLabels":44,"otherNames":45},"Pembrolizumab",[31],[46],"KEYTRUDA®",[48],{"name":49,"affiliation":50,"role":51},"Teva Medical Expert, MD","Teva Branded Pharmaceutical Products R&D LLC","STUDY_DIRECTOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":41,"email":57},"Teva U.S. Medical Information","CONTACT","1-888-483-8279","USMedInfo@tevapharm.com",[59,73,84,94,104,114,124,134,144,150,160,170],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":41},"Teva Investigational Site 12017","RECRUITING","Los Angeles","California","90025","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-118.24368,34.05223,{"lat":71,"lon":70},{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":65,"countryCode":66,"cosmosGeoPoint":79,"geoPoint":83,"contacts":41},"Teva Investigational Site 12021","COMPLETED","Lake Mary","Florida","32746",{"type":68,"coordinates":80},[81,82],-81.31784,28.75888,{"lat":82,"lon":81},{"facility":85,"status":61,"city":86,"state":87,"zip":88,"country":65,"countryCode":66,"cosmosGeoPoint":89,"geoPoint":93,"contacts":41},"Teva Investigational Site 12016","Chicago","Illinois","60611",{"type":68,"coordinates":90},[91,92],-87.65005,41.85003,{"lat":92,"lon":91},{"facility":95,"status":61,"city":96,"state":97,"zip":98,"country":65,"countryCode":66,"cosmosGeoPoint":99,"geoPoint":103,"contacts":41},"Teva Investigational Site 12015","Detroit","Michigan","48201",{"type":68,"coordinates":100},[101,102],-83.04575,42.33143,{"lat":102,"lon":101},{"facility":105,"status":61,"city":106,"state":107,"zip":108,"country":65,"countryCode":66,"cosmosGeoPoint":109,"geoPoint":113,"contacts":41},"Teva Investigational Site 12014","Huntersville","North Carolina","28078",{"type":68,"coordinates":110},[111,112],-80.84285,35.41069,{"lat":112,"lon":111},{"facility":115,"status":61,"city":116,"state":117,"zip":118,"country":65,"countryCode":66,"cosmosGeoPoint":119,"geoPoint":123,"contacts":41},"Teva Investigational Site 12023","Cincinnati","Ohio","45219",{"type":68,"coordinates":120},[121,122],-84.51439,39.12711,{"lat":122,"lon":121},{"facility":125,"status":61,"city":126,"state":127,"zip":128,"country":65,"countryCode":66,"cosmosGeoPoint":129,"geoPoint":133,"contacts":41},"Teva Investigational Site 12058","Pittsburgh","Pennsylvania","15232",{"type":68,"coordinates":130},[131,132],-79.99589,40.44062,{"lat":132,"lon":131},{"facility":135,"status":61,"city":136,"state":137,"zip":138,"country":65,"countryCode":66,"cosmosGeoPoint":139,"geoPoint":143,"contacts":41},"Teva Investigational Site 12019","Nashville","Tennessee","37203",{"type":68,"coordinates":140},[141,142],-86.78444,36.16589,{"lat":142,"lon":141},{"facility":145,"status":61,"city":136,"state":137,"zip":146,"country":65,"countryCode":66,"cosmosGeoPoint":147,"geoPoint":149,"contacts":41},"Teva Investigational Site 12024","37232",{"type":68,"coordinates":148},[141,142],{"lat":142,"lon":141},{"facility":151,"status":61,"city":152,"state":153,"zip":154,"country":65,"countryCode":66,"cosmosGeoPoint":155,"geoPoint":159,"contacts":41},"Teva Investigational Site 12018","Fairfax","Virginia","22031",{"type":68,"coordinates":156},[157,158],-77.30637,38.84622,{"lat":158,"lon":157},{"facility":161,"status":61,"city":162,"state":163,"zip":164,"country":65,"countryCode":66,"cosmosGeoPoint":165,"geoPoint":169,"contacts":41},"Teva Investigational Site 12025","Milwaukee","Wisconsin","53226",{"type":68,"coordinates":166},[167,168],-87.90647,43.0389,{"lat":168,"lon":167},{"facility":171,"status":61,"city":172,"state":173,"zip":174,"country":175,"countryCode":176,"cosmosGeoPoint":177,"geoPoint":181,"contacts":41},"Teva Investigational Site 11282","Toronto","Ontario","M5G 2M9","Canada","CA",{"type":68,"coordinates":178},[179,180],-79.39864,43.70643,{"lat":180,"lon":179},{"type":183,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100553012",false,"NCT06480552","An Open-label Dose Escalation\u002FExpansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors","A Phase 1a\u002F1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety and Activity of TEV-56278, as a Monotherapy and in Combination With Pembrolizumab in Participants With Selected Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Have an established histological diagnosis of selected solid tumor and must have received and progressed on established standard therapies or have been intolerant to such therapy or have been considered by the Investigator as ineligible for approved standard therapy\n* Have a life expectancy≥12 weeks at the time of the screening\n* Women of childbearing potential must agree to use highly effective methods of contraception for the course of the trial through 120 days after the last dose of trial medication\n* Males who are sexually active with women of childbearing potential must agree to use condoms and refrain from donating sperm for the course of the trial through 120 days after the last dose of trial medication\n\nNOTE- Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* Has a history of systemic treatment therapy for cancer (including chemotherapy, immunotherapy, radiotherapy, or other investigational drug) or surgery within 4 weeks prior to baseline\n* Is currently receiving or has received hematopoietic colony-stimulating growth factors within 2 weeks before screening or transfusion support 4 weeks prior to screening\n* Has a diagnosis of immunodeficiency\n* Has active known autoimmune disease.\n* Has a history of or known active brain metastases and\u002For carcinomatous meningitis and\u002For leptomeningeal metastasis\n* Has active or uncontrolled serious infections requiring systemic therapy within 14 days prior to baseline\n* Has a history of clinically significant cardiovascular or cerebrovascular disease in previous 6 months prior to screening\n* Has evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis\n* Has a seizure disorder requiring therapy (such as steroids or antiepileptics)\n\nNOTE- Additional criteria apply, please contact the investigator for more information","ALL","18 Years",{"count":193,"type":194},240,"ESTIMATED","INTERVENTIONAL",[197],"PHASE1","The primary objectives of this trial are to:\n\n* Characterize the safety and tolerability of TEV-56278\n* Determine the Recommended Phase 2 Dose (RP2D)\n* Evaluate antitumor activity of TEV-56278 (Part 2 only)\n* Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab\n* Determine a RP2D of TEV-56278 in combination with pembrolizumab\n\nThe secondary objectives of this trial are to:\n\n* Characterize the serum pharmacokinetics of TEV-56278\n* Evaluate the antitumor activity of TEV-56278\n* Determine the safety and tolerability of TEV-56278\n* Evaluate other measures of antitumor activity of TEV-56278\n* Evaluate anti-tumor activity\n\nParticipants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. The total duration of the trial will be up to 25 months for individual participants.\n\nParticipants who exhibit a favorable benefit risk profile at the end of the 12 month trial treatment period may be offered an opportunity for an extended treatment period in which they can be treated for a maximum of 12 additional months (up to 26 additional cycles of TEV-56278).",[200],"Advanced Solid Tumors","2026-06-02",{"date":203,"type":204},"2026-06-04","ACTUAL",{"date":206,"type":204},"2024-07-22",{"date":208,"type":194},"2031-02-25",{"name":50,"class":6},12]