[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514988":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":191,"collaborators":39,"id":193,"slug":194,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":195,"sex":201,"minAge":202,"maxAge":39,"enrollmentInfo":203,"targetDuration":39,"studyType":206,"phases":207,"briefSummary":210,"conditions":211,"keywords":218,"overallStatus":54,"whyStopped":39,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"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",[52,66,76,86,96,106,118,123,134,147,158,169,180],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":39},"USC Norris Comprehensive Cancer Center","RECRUITING","Los Angeles","California","90089","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-118.24368,34.05223,{"lat":64,"lon":63},{"facility":67,"status":54,"city":68,"state":69,"zip":70,"country":58,"countryCode":59,"cosmosGeoPoint":71,"geoPoint":75,"contacts":39},"START Midwest","Grand Rapids","Michigan","49546",{"type":61,"coordinates":72},[73,74],-85.66809,42.96336,{"lat":74,"lon":73},{"facility":77,"status":54,"city":78,"state":79,"zip":80,"country":58,"countryCode":59,"cosmosGeoPoint":81,"geoPoint":85,"contacts":39},"START San Antonio","San Antonio","Texas","78229",{"type":61,"coordinates":82},[83,84],-98.49363,29.42412,{"lat":84,"lon":83},{"facility":87,"status":54,"city":88,"state":89,"zip":90,"country":58,"countryCode":59,"cosmosGeoPoint":91,"geoPoint":95,"contacts":39},"START Mountain Region","West Valley City","Utah","84119",{"type":61,"coordinates":92},[93,94],-112.00105,40.69161,{"lat":94,"lon":93},{"facility":97,"status":54,"city":98,"state":39,"zip":39,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":39},"GZA Ziekenhuizen - Campus Sint-Augustinus","Antwerp","Belgium","BE",{"type":61,"coordinates":102},[103,104],4.40026,51.22047,{"lat":104,"lon":103},{"facility":107,"status":54,"city":108,"state":39,"zip":39,"country":99,"countryCode":100,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Clinique Universitaires Saint-Luc","Brussels",{"type":61,"coordinates":110},[111,112],4.34878,50.85045,{"lat":112,"lon":111},[115],{"name":116,"role":117,"phone":39,"phoneExt":39,"email":39},"Rachel Galot","PRINCIPAL_INVESTIGATOR",{"facility":119,"status":54,"city":108,"state":39,"zip":39,"country":99,"countryCode":100,"cosmosGeoPoint":120,"geoPoint":122,"contacts":39},"Institute Jules Bordet",{"type":61,"coordinates":121},[111,112],{"lat":112,"lon":111},{"facility":124,"status":54,"city":125,"state":39,"zip":39,"country":99,"countryCode":100,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"CHU Sart Tilman","Liège",{"type":61,"coordinates":127},[128,129],5.56749,50.63373,{"lat":129,"lon":128},[132],{"name":133,"role":117,"phone":39,"phoneExt":39,"email":39},"Laurence Lousberg",{"facility":135,"status":54,"city":136,"state":39,"zip":39,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"The Beatson West of Scotland Cancer Centre","Glasgow","United Kingdom","UK",{"type":61,"coordinates":140},[141,142],-4.25763,55.86515,{"lat":142,"lon":141},[145],{"name":146,"role":117,"phone":39,"phoneExt":39,"email":39},"Jeff Evans",{"facility":148,"status":54,"city":149,"state":39,"zip":39,"country":137,"countryCode":138,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"UCL Hospitals NHS Foundation Trust","London",{"type":61,"coordinates":151},[152,153],-0.12574,51.50853,{"lat":153,"lon":152},[156],{"name":157,"role":117,"phone":39,"phoneExt":39,"email":39},"Martin Forster",{"facility":159,"status":54,"city":160,"state":39,"zip":39,"country":137,"countryCode":138,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"The Christie NHS Foundation Trust","Manchester",{"type":61,"coordinates":162},[163,164],-2.23743,53.48095,{"lat":164,"lon":163},[167],{"name":168,"role":117,"phone":39,"phoneExt":39,"email":39},"Donna Graham",{"facility":170,"status":54,"city":171,"state":39,"zip":39,"country":137,"countryCode":138,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Newcastle Upon Tyne NHS Foundation Trust","Newcastle upon Tyne",{"type":61,"coordinates":173},[174,175],-1.61396,54.97328,{"lat":175,"lon":174},[178],{"name":179,"role":117,"phone":39,"phoneExt":39,"email":39},"Elizabeth Ruth Plummer",{"facility":181,"status":54,"city":182,"state":39,"zip":39,"country":137,"countryCode":138,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Oxford University Hospitals NHS Foundation Trust","Oxford",{"type":61,"coordinates":184},[185,186],-1.25596,51.75222,{"lat":186,"lon":185},[189],{"name":190,"role":117,"phone":39,"phoneExt":39,"email":39},"Simon Lord",{"type":192,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100514988","phase-1-study-to-assess-gtaexs617-in-participants-with-advanced-solid-tumors-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":204,"type":205},230,"ESTIMATED","INTERVENTIONAL",[208,209],"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.",[212,213,214,215,216,217],"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)",[219],"Advanced Solid Tumor","2026-04-22",{"date":222,"type":223},"2026-04-23","ACTUAL",{"date":225,"type":223},"2023-07-06",{"date":227,"type":205},"2028-05",{"name":47,"class":6},13]