[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640517":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":41,"studyPopulation":33,"armGroups":42,"interventions":54,"overallOfficials":33,"centralContacts":63,"locations":69,"responsibleParty":179,"collaborators":33,"id":181,"slug":33,"hasResults":182,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":33,"eligibilityCriteria":186,"healthyVolunteers":182,"sex":187,"minAge":188,"maxAge":33,"enrollmentInfo":189,"targetDuration":33,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":33,"overallStatus":152,"whyStopped":33,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"NEOK Bio, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":33},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)","Incidence and severity of DLTs during the first cycle of treatment in Part A","21 days",{"measure":14,"description":15,"timeFrame":16},"Part A: Incidence and Severity of Adverse Events (AEs)","Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients in Part A","Through study completion, estimated as 32 months",{"measure":18,"description":19,"timeFrame":16},"Part B: Investigator Assessment of Objective Response Rate (ORR)","Percentage of patients who achieve a confirmed objective response (ORR)",{"measure":21,"description":22,"timeFrame":16},"Part B: Duration of Response (DOR)","The time from the first documentation of tumor response (complete or partial) until disease progression or death.",[24,27,30],{"measure":25,"description":26,"timeFrame":16},"Part B: Incidence of AEs","Incidence of TEAEs and SAEs in participants in Part B",{"measure":28,"description":29,"timeFrame":12},"Maximum Concentration (Cmax) of NEOK002","Assessment of plasma pharmacokinetics (PK) parameters of NEOK002: Cmax",{"measure":31,"description":32,"timeFrame":12},"Terminal Elimination Half Life (T1\u002F2) of NEOK002","Assessment of plasma PK parameters of NEOK002: T1\u002F2",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"NON_RANDOMIZED","SEQUENTIAL","Dose Escalation followed by Dose Expansion","TREATMENT",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE","This is a FIH, Phase 1, open-label, multicenter, multiple-dose, dose escalation and expansion study. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B). NEOK001 is a bispecific EGFR and MUC1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Dose Escalation","EXPERIMENTAL","NEOK002",[48],"Drug: NEOK002",{"label":50,"type":45,"description":51,"interventionNames":52},"Dose Expansion","Recommended Dose of NEOK002 for Expansion",[53],"Drug: NEOK002 RDE",[55,59],{"type":56,"name":46,"description":57,"armGroupLabels":58,"otherNames":33},"DRUG","Escalating doses of NEOK002",[44],{"type":56,"name":60,"description":61,"armGroupLabels":62,"otherNames":33},"NEOK002 RDE","Recommended NEOK002 dose(s) for Expansion",[50],[64],{"name":65,"role":66,"phone":67,"phoneExt":33,"email":68},"Beth Lepping, RN, BSN, MS","CONTACT","610-207-2119","blepping@neokbio.com",[70,86,101,116,129,141,151,165],{"facility":71,"status":72,"city":73,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Memorial Sloan Kettering Cancer Center","NOT_YET_RECRUITING","New York","10065","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-74.00597,40.71427,{"lat":81,"lon":80},[84],{"name":33,"role":66,"phone":85,"phoneExt":33,"email":33},"646-888-4167",{"facility":87,"status":72,"city":88,"state":89,"zip":90,"country":75,"countryCode":76,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":78,"coordinates":92},[93,94],-86.78444,36.16589,{"lat":94,"lon":93},[97],{"name":98,"role":66,"phone":99,"phoneExt":33,"email":100},"Tracey Zimmer","972-566-3000","Tracey.Zimmer@scri.com",{"facility":102,"status":72,"city":103,"state":104,"zip":105,"country":75,"countryCode":76,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"NEXT Oncology","Austin","Texas","78758",{"type":78,"coordinates":107},[108,109],-97.74306,30.26715,{"lat":109,"lon":108},[112],{"name":113,"role":66,"phone":114,"phoneExt":33,"email":115},"Heather Watson","737-610-5202","hwatson@nextoncology.com",{"facility":102,"status":72,"city":117,"state":104,"zip":118,"country":75,"countryCode":76,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Dallas","78299",{"type":78,"coordinates":120},[121,122],-96.80667,32.78306,{"lat":122,"lon":121},[125],{"name":126,"role":66,"phone":127,"phoneExt":33,"email":128},"Mofopefoluwa \"Fope\" Akinwale","972-893-8800","fakinwale@nextoncology.com",{"facility":130,"status":72,"city":131,"state":104,"zip":132,"country":75,"countryCode":76,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"MD Anderson Cancer Center","Houston","77030",{"type":78,"coordinates":134},[135,136],-95.36327,29.76328,{"lat":136,"lon":135},[139],{"name":33,"role":66,"phone":140,"phoneExt":33,"email":33},"713-563-1055",{"facility":102,"status":72,"city":131,"state":104,"zip":142,"country":75,"countryCode":76,"cosmosGeoPoint":143,"geoPoint":145,"contacts":146},"77054",{"type":78,"coordinates":144},[135,136],{"lat":136,"lon":135},[147],{"name":148,"role":66,"phone":149,"phoneExt":33,"email":150},"Emma Morales","832-384-7912","emorales@nextoncology.com",{"facility":102,"status":152,"city":153,"state":104,"zip":154,"country":75,"countryCode":76,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"RECRUITING","San Antonio","75039",{"type":78,"coordinates":156},[157,158],-98.49363,29.42412,{"lat":158,"lon":157},[161],{"name":162,"role":66,"phone":163,"phoneExt":33,"email":164},"Jordan Georg","210-580-9521","Jgeorg@nextoncology.com",{"facility":102,"status":72,"city":166,"state":167,"zip":168,"country":75,"countryCode":76,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Fairfax","Virginia","22031",{"type":78,"coordinates":170},[171,172],-77.30637,38.84622,{"lat":172,"lon":171},[175],{"name":176,"role":66,"phone":177,"phoneExt":33,"email":178},"Maybelle De La Rosa","703-783-4518","Mdelarosa@nextoncology.com",{"type":180,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100640517",false,"NCT07612189","A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid Tumors","A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific Antibody-Drug, Conjugate in Participants With Select Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Participants must have locally advanced or metatstatic disease in a select tumor type, for which no standard therapy is available.\n* Participants must have at least 1 measurable target lesion based on RECIST v1.1.\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate hematologic, hepatic, and renal function.\n* Participants should have available archived tumor tissue from their most recent biopsy.\n\nKey Exclusion Criteria:\n\n* Participant's most recent systemic anti-cancer treatment was an ADC with a topoisomerase 1-inhibitor payload component.\n* Participant with known symptomatic central nervous system (CNS) metastases or any evidence of leptomeningeal disease or evidence of unstable CNS metastases, even if asymptomatic.\n* Participants with a known history of interstitial lung disease (ILD) requiring steroid treatment, or for whom suspected ILD cannot be ruled out by imaging at screening.\n* Participants with clinically severe pulmonary compromise due to intercurrent pulmonary illness and\u002For pulmonary disorder requiring supplemental oxygen or any prior pneumonectomy.\n* Participants with a QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec.","ALL","18 Years",{"count":190,"type":191},155,"ESTIMATED","INTERVENTIONAL",[194],"PHASE1","This is a first in human (FIH), Phase 1 dose escalation and expansion study in select solid tumors. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B).",[197],"Locally Advanced (Unresectable) or Metastatic Solid Tumors","2026-05-28",{"date":200,"type":201},"2026-06-01","ACTUAL",{"date":203,"type":201},"2026-04-22",{"date":205,"type":191},"2029-02",{"name":5,"class":6},8]