[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620741":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":99,"collaborators":28,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":28,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":28,"enrollmentInfo":110,"targetDuration":28,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":124,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Cogent Biosciences, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","Part A: Dose Escalation Multiple doses of CGT4255 for oral administration",[13],"Drug: CGT4255",{"label":15,"type":10,"description":16,"interventionNames":17},"Signal Seeking and Dose Escalation","Part B: Signal Seeking and Dose Optimization Oral dose(s) of CGT4255 at the selected dose levels determined in Phase 1",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Signal Seeking","Part C: Includes signal seeking. Participants will receive CGT4255 at a dose level selected based on data from Part A",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","CGT4255","CGT4255 Daily Oral Administration",[9,19,15],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Cogent Biosciences, Inc","CONTACT","617-945-5576","trialinfo@cogentbio.com",[36,50,59,69,79,89],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":28},"START Midwest","RECRUITING","Grand Rapids","Michigan","49546","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-85.66809,42.96336,{"lat":48,"lon":47},{"facility":51,"status":38,"city":52,"state":52,"zip":53,"country":42,"countryCode":43,"cosmosGeoPoint":54,"geoPoint":58,"contacts":28},"NYU Langone","New York","10016",{"type":45,"coordinates":55},[56,57],-74.00597,40.71427,{"lat":57,"lon":56},{"facility":60,"status":38,"city":61,"state":62,"zip":63,"country":42,"countryCode":43,"cosmosGeoPoint":64,"geoPoint":68,"contacts":28},"Tennessee Oncology","Nashville","Tennessee","37203",{"type":45,"coordinates":65},[66,67],-86.78444,36.16589,{"lat":67,"lon":66},{"facility":70,"status":38,"city":71,"state":72,"zip":73,"country":42,"countryCode":43,"cosmosGeoPoint":74,"geoPoint":78,"contacts":28},"NEXT Oncology Texas","Austin","Texas","78758",{"type":45,"coordinates":75},[76,77],-97.74306,30.26715,{"lat":77,"lon":76},{"facility":80,"status":38,"city":81,"state":82,"zip":83,"country":42,"countryCode":43,"cosmosGeoPoint":84,"geoPoint":88,"contacts":28},"START Mountain Region","West Valley City","Utah","84119",{"type":45,"coordinates":85},[86,87],-112.00105,40.69161,{"lat":87,"lon":86},{"facility":90,"status":38,"city":91,"state":92,"zip":93,"country":42,"countryCode":43,"cosmosGeoPoint":94,"geoPoint":98,"contacts":28},"NEXT Oncology Virginia","Fairfax","Virginia","22031",{"type":45,"coordinates":95},[96,97],-77.30637,38.84622,{"lat":97,"lon":96},{"type":100,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100620741","phase-1-a-study-of-a-selective-erbb2-inhibitor-cgt4255-in-patients-with-advanced-solid-tumors-100620741",false,"NCT07361562","A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors","A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression","Inclusion Criteria:\n\n1. Have histologically confirmed diagnosis of:\n\n   1. Part A: Locally advanced, metastatic, and\u002For unresectable solid tumor with documented ERBB2-activating alteration or NRG1 gene fusion in blood and\u002For tumor or HER2 overexpression in tumor\n   2. Part B: Locally advanced, metastatic, and\u002For unresectable NSCLC with documented ERBB2 mutation in blood and\u002For tumor\n   3. Part C: Locally advanced, metastatic and\u002For unresectable breast cancer with documented ERBB2 mutation in blood and\u002For tumor or HER overexpression in tumor\n2. Have measurable disease per RECIST v1.1.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 for Part A. For Parts B and C, ECOG Performance Status must be 0 to 2.\n4. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.\n\nExclusion Criteria:\n\n1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.\n2. Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug.\n3. Treatment with palliative focal radiotherapy (cranial or extracranial) (eg, stereotactic radiosurgery or intensity-modulated radiation therapy) ≤2 weeks before the first dose of study drug; treatment with whole-brain radiotherapy ≤4 weeks before the first dose of study drug.\n4. Clinically significant cardiac disease.\n5. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug.\n6. Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.","ALL","18 Years",{"count":111,"type":112},100,"ESTIMATED","INTERVENTIONAL",[115],"PHASE1","This is an open-label, phase 1\u002F1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.",[118,119,120,121,122,123],"Advanced Solid Tumor, Adult","ERBB2 Altered Breast Cancer","ERBB2 Gene Amplification","HER2 Overexpression","Non-Small Cell Lung Cancer","HER2",[125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,123],"ERBB2 genetic alterations","Investigational Drug","Advanced Solid Tumors","ERBB2 Mutated Non Small Cell Lung Cancer","Mutated Advanced Solid Tumors","ERBB2 Brain Metastases","ERRB2 Point Mutations","ERBB2 Gene Short Variants","ERBB2 Gene Rearrangements","ERBB2 activation alteration","ERBB2 gene copy number amplifications","ERBB2 gene insertions","ERRB2 gene deletions","ERBB2 gene fusions","NRG1 gene fusions","ERBB2 indel","Phase 1\u002F1b","HER2 Protein Overexpression","2026-02-25",{"date":145,"type":146},"2026-02-27","ACTUAL",{"date":148,"type":146},"2025-12-30",{"date":150,"type":112},"2028-11",{"name":5,"class":6},6]