[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514988":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":188,"collaborators":39,"id":190,"slug":39,"hasResults":191,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":191,"sex":197,"minAge":198,"maxAge":39,"enrollmentInfo":199,"targetDuration":39,"studyType":202,"phases":203,"briefSummary":206,"conditions":207,"keywords":214,"overallStatus":54,"whyStopped":39,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},{"fullName":5,"class":6},"Exscientia AI Limited","INDUSTRY",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1: Dose Escalation Monotherapy","EXPERIMENTAL","Participants will receive GTAEXS617 oral tablets in increasing doses.",[13],"Drug: GTAEXS617",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1: Dose Escalation Combination Therapy","Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.",[13,18],"Drug: SoC",{"label":20,"type":10,"description":21,"interventionNames":22},"Phase 2: Dose Expansion Monotherapy","Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Phase 2: Dose Expansion Combination Therapy","Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.",[13,18],[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","GTAEXS617","Administered as specified in the treatment arm.",[15,9,24,20],[34],"REC-617",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"SoC","Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.",[15,24],null,[41],{"name":42,"affiliation":43,"role":44},"Medical Director","Exscientia AI Ltd.","STUDY_DIRECTOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":39,"email":50},"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.","CONTACT","385-374-1724","clinicaltrials@recursionpharma.com",[52,65,75,85,95,104,116,121,132,144,155,166,177],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":39},"USC Norris Comprehensive Cancer Center","RECRUITING","Los Angeles","California","90089","United States",{"type":60,"coordinates":61},"Point",[62,63],-118.24368,34.05223,{"lat":63,"lon":62},{"facility":66,"status":54,"city":67,"state":68,"zip":69,"country":58,"cosmosGeoPoint":70,"geoPoint":74,"contacts":39},"START Midwest","Grand Rapids","Michigan","49546",{"type":60,"coordinates":71},[72,73],-85.66809,42.96336,{"lat":73,"lon":72},{"facility":76,"status":54,"city":77,"state":78,"zip":79,"country":58,"cosmosGeoPoint":80,"geoPoint":84,"contacts":39},"START San Antonio","San Antonio","Texas","78229",{"type":60,"coordinates":81},[82,83],-98.49363,29.42412,{"lat":83,"lon":82},{"facility":86,"status":54,"city":87,"state":88,"zip":89,"country":58,"cosmosGeoPoint":90,"geoPoint":94,"contacts":39},"START Mountain Region","West Valley City","Utah","84119",{"type":60,"coordinates":91},[92,93],-112.00105,40.69161,{"lat":93,"lon":92},{"facility":96,"status":54,"city":97,"state":39,"zip":39,"country":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":39},"GZA Ziekenhuizen - Campus Sint-Augustinus","Antwerp","Belgium",{"type":60,"coordinates":100},[101,102],4.40026,51.22047,{"lat":102,"lon":101},{"facility":105,"status":54,"city":106,"state":39,"zip":39,"country":98,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Clinique Universitaires Saint-Luc","Brussels",{"type":60,"coordinates":108},[109,110],4.34878,50.85045,{"lat":110,"lon":109},[113],{"name":114,"role":115,"phone":39,"phoneExt":39,"email":39},"Rachel Galot","PRINCIPAL_INVESTIGATOR",{"facility":117,"status":54,"city":106,"state":39,"zip":39,"country":98,"cosmosGeoPoint":118,"geoPoint":120,"contacts":39},"Institute Jules Bordet",{"type":60,"coordinates":119},[109,110],{"lat":110,"lon":109},{"facility":122,"status":54,"city":123,"state":39,"zip":39,"country":98,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"CHU Sart Tilman","Liège",{"type":60,"coordinates":125},[126,127],5.56749,50.63373,{"lat":127,"lon":126},[130],{"name":131,"role":115,"phone":39,"phoneExt":39,"email":39},"Laurence Lousberg",{"facility":133,"status":54,"city":134,"state":39,"zip":39,"country":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"The Beatson West of Scotland Cancer Centre","Glasgow","United Kingdom",{"type":60,"coordinates":137},[138,139],-4.25763,55.86515,{"lat":139,"lon":138},[142],{"name":143,"role":115,"phone":39,"phoneExt":39,"email":39},"Jeff Evans",{"facility":145,"status":54,"city":146,"state":39,"zip":39,"country":135,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"UCL Hospitals NHS Foundation Trust","London",{"type":60,"coordinates":148},[149,150],-0.12574,51.50853,{"lat":150,"lon":149},[153],{"name":154,"role":115,"phone":39,"phoneExt":39,"email":39},"Martin Forster",{"facility":156,"status":54,"city":157,"state":39,"zip":39,"country":135,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"The Christie NHS Foundation Trust","Manchester",{"type":60,"coordinates":159},[160,161],-2.23743,53.48095,{"lat":161,"lon":160},[164],{"name":165,"role":115,"phone":39,"phoneExt":39,"email":39},"Donna Graham",{"facility":167,"status":54,"city":168,"state":39,"zip":39,"country":135,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Newcastle Upon Tyne NHS Foundation Trust","Newcastle upon Tyne",{"type":60,"coordinates":170},[171,172],-1.61396,54.97328,{"lat":172,"lon":171},[175],{"name":176,"role":115,"phone":39,"phoneExt":39,"email":39},"Elizabeth Ruth Plummer",{"facility":178,"status":54,"city":179,"state":39,"zip":39,"country":135,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Oxford University Hospitals NHS Foundation Trust","Oxford",{"type":60,"coordinates":181},[182,183],-1.25596,51.75222,{"lat":183,"lon":182},[186],{"name":187,"role":115,"phone":39,"phoneExt":39,"email":39},"Simon Lord",{"type":189,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100514988",false,"NCT05985655","Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors","ELUCIDATE","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy \\> 3 months.\n* One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive \\[HR+\\] and Human Epidermal Growth Receptor 2 negative \\[HER2-\\] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)\u002F Cyclin-Dependent Kinase 6 \\[CDK6\\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC).\n* Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments.\n* Adequate hematological, liver, and renal function.\n* Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.\n\nKey Exclusion Criteria:\n\n* Active and clinically significant (CS) infection.\n* Refractory nausea and\u002For vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617.\n* Symptomatic central nervous system (CNS) malignancy or metastases.\n* Concurrent active or previous malignancy.\n* Prior organ or allogeneic stem-cell transplantation.\n* Moderate or severe cardiovascular disease.\n* Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.\n* Received treatment with known strong\u002Fmoderate inhibitors and\u002For strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment.\n* Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment.\n* Received treatment with known substrates of organic anion transporting peptide or BCRP within 14 days or 5 half-lives before the first dose of study treatment.\n* Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy\n* Has had or is scheduled to have major surgery \\\u003C28 days prior to the first dose of study treatment.\n\nNote: Other protocol Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":200,"type":201},230,"ESTIMATED","INTERVENTIONAL",[204,205],"PHASE1","PHASE2","The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.",[208,209,210,211,212,213],"Head and Neck Squamous Cell Carcinoma (HNSCC)","Pancreatic Adenocarcinoma","Non-small Cell Lung Cancer (NSCLC)","Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)","Hormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast Carcinoma","Triple Negative Breast Cancer (TNBC)",[215],"Advanced Solid Tumor","2026-04-22",{"date":218,"type":219},"2026-04-23","ACTUAL",{"date":221,"type":219},"2023-07-06",{"date":223,"type":201},"2028-05",{"name":47,"class":6},13]