[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577940":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":42,"locations":48,"responsibleParty":139,"collaborators":34,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":34,"eligibilityCriteria":147,"healthyVolunteers":143,"sex":148,"minAge":149,"maxAge":34,"enrollmentInfo":150,"targetDuration":34,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":51,"whyStopped":34,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Vividion Therapeutics, Inc.","INDUSTRY",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Dose Escalation: VVD-159642 Single Agent","EXPERIMENTAL","Participants will receive ascending doses of VVD-159642, orally, daily in 21-day treatment cycles during Part 1.",[13],"Drug: VVD-159642",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2: Dose Expansion (Cohort A): VVD-159642 Single Agent","Participants will receive VVD-159642 at the recommended dose for expansion (RDE), orally, daily in 21-day treatment cycles during Part 2.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 2: Dose Expansion (Cohort B): VVD-159642 + Sotorasib","Participants will receive VVD-159642 at RDE orally, daily in combination with sotorasib, in 21-day treatment cycles after a safety run-in.",[13,22],"Drug: Sotorasib",{"label":24,"type":10,"description":25,"interventionNames":26},"Part 2: Dose Expansion (Cohort C): VVD-159642 + Trametinib","Participants will receive VVD-159642 at RDE orally, daily in combination with trametinib, in 21-day treatment cycles after a safety run-in.",[13,27],"Drug: Trametinib",[29,35,39],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","VVD-159642","Oral capsules",[9,15,19,24],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Sotorasib","Oral tablets",[19],{"type":30,"name":40,"description":37,"armGroupLabels":41,"otherNames":34},"Trametinib",[24],[43],{"name":44,"role":45,"phone":46,"phoneExt":34,"email":47},"Vividion Clinical Trial Call Center","CONTACT","858-345-9752","clinicaltrials@vividion.com",[49,63,73,82,91,97,107,117,129],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":34},"START Mid West","RECRUITING","Grand Rapids","Michigan","49546","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-85.66809,42.96336,{"lat":61,"lon":60},{"facility":64,"status":51,"city":65,"state":66,"zip":67,"country":55,"countryCode":56,"cosmosGeoPoint":68,"geoPoint":72,"contacts":34},"NEXT Austin","Austin","Texas","78758",{"type":58,"coordinates":69},[70,71],-97.74306,30.26715,{"lat":71,"lon":70},{"facility":74,"status":51,"city":75,"state":66,"zip":76,"country":55,"countryCode":56,"cosmosGeoPoint":77,"geoPoint":81,"contacts":34},"NEXT Dallas","Irving","75039",{"type":58,"coordinates":78},[79,80],-96.94889,32.81402,{"lat":80,"lon":79},{"facility":83,"status":51,"city":84,"state":66,"zip":85,"country":55,"countryCode":56,"cosmosGeoPoint":86,"geoPoint":90,"contacts":34},"START San Antonio","San Antonio","78229",{"type":58,"coordinates":87},[88,89],-98.49363,29.42412,{"lat":89,"lon":88},{"facility":92,"status":51,"city":84,"state":66,"zip":93,"country":55,"countryCode":56,"cosmosGeoPoint":94,"geoPoint":96,"contacts":34},"NEXT San Antonio","78299",{"type":58,"coordinates":95},[88,89],{"lat":89,"lon":88},{"facility":98,"status":51,"city":99,"state":100,"zip":101,"country":55,"countryCode":56,"cosmosGeoPoint":102,"geoPoint":106,"contacts":34},"START Mountain","Ogden","Utah","84401",{"type":58,"coordinates":103},[104,105],-111.97383,41.223,{"lat":105,"lon":104},{"facility":108,"status":51,"city":109,"state":110,"zip":111,"country":55,"countryCode":56,"cosmosGeoPoint":112,"geoPoint":116,"contacts":34},"NEXT Virginia","Fairfax","Virginia","22031",{"type":58,"coordinates":113},[114,115],-77.30637,38.84622,{"lat":115,"lon":114},{"facility":118,"status":51,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":128,"contacts":34},"Clinical Research South Australia (CRSA)","Adelaide","South Australia","5000","Australia","AU",{"type":58,"coordinates":125},[126,127],138.59863,-34.92866,{"lat":127,"lon":126},{"facility":130,"status":51,"city":131,"state":132,"zip":133,"country":122,"countryCode":123,"cosmosGeoPoint":134,"geoPoint":138,"contacts":34},"Linear Clinical","Nedlands","Western Australia","6009",{"type":58,"coordinates":135},[136,137],115.8073,-31.98184,{"lat":137,"lon":136},{"type":140,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100577940","phase-1-a-first-in-human-fih-study-to-evaluate-the-safety-and-tolerability-of-vvd-159642-in-participants-with-advanced-solid-tumors-100577940",false,"NCT06804824","A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b, Open-Label, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-159642, a RAS-PI3Kα Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or any solid tumor that harbors a rat sarcoma viral oncogene (RAS) alteration \\[Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), Harvey rat sarcoma viral oncogene homolog (HRAS)\\] as per local \u002Fhistorical testing; any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local\u002Fhistorical testing; or human epidermal growth factor receptor 2 (HER2) overexpression (immunohistochemistry \\[IHC\\] 3+ or IHC 2+\u002Ffluorescence in situ hybridization \\[FISH\\] positive) as per local\u002Fhistorical testing.\n* Have histologically or cytologically confirmed metastatic or unresectable solid tumors.\n* Measurable disease by RECIST version 1.1 as assessed by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Adequate bone marrow, kidney, and liver function as defined in the protocol.\n* Able to take oral medications.\n\nKey Exclusion Criteria:\n\n* Active central nervous system (CNS) malignancies.\n* History of cardiac diseases as defined in detail in the protocol.\n* Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).\n* History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and\u002For may interfere with the conduct of the study.\n* Active hepatitis B infection \\[positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)\\].\n* Active hepatitis C infection (positive anti-hepatitis C virus \\[HCV\\] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay).","ALL","18 Years",{"count":151,"type":152},220,"ESTIMATED","INTERVENTIONAL",[155],"PHASE1","A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.",[158],"Advanced Solid Tumors",[160,161,162,163,164,165,166,167],"RAS","PI3K","KRAS","MEK","Phase I","solid tumors","KRAS G12C","HER2","2026-03-16",{"date":170,"type":171},"2026-03-18","ACTUAL",{"date":173,"type":171},"2025-02-25",{"date":175,"type":152},"2027-08-01",{"name":5,"class":6},9]