[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NEOK Bio, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100640517","phase-1-a-study-of-neok002-an-egfr-and-muc1-targeting-bispecific-adc-in-participants-with-select-solid-tumors-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":19,"type":20},155,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26],"Locally Advanced (Unresectable) or Metastatic Solid Tumors","RECRUITING","2026-05-28",{"date":30,"type":31},"2026-06-01","ACTUAL",{"date":33,"type":31},"2026-04-22",{"date":35,"type":20},"2029-02",{"name":37,"class":38},"NEOK Bio, Inc.","INDUSTRY",8,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":51,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":39},"100640013","phase-1-a-phase-1-study-of-neok001-a-b7-h3-and-ror1-targeting-bispecific-adc-in-participants-with-select-solid-tumors-100640013","NCT07612176","A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors","A Phase 1 Dose Escalation and Expansion Study of NEOK001, a B7-H3 and ROR1 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 metastatic 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* Participants 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.",{"count":19,"type":20},[23],"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).",[26],[52,53,54,55,56,57,58,59,60,61],"Antibody-Drug Conjugate","ADC","Bispecific","B7-H3","ROR1","Locally Advanced","Unresectable","Metastatic","Solid Tumor","oncology","2026-05-21",{"date":28,"type":31},{"date":65,"type":31},"2026-04-21",{"date":67,"type":20},"2029-01",{"name":37,"class":38},""]