[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512581":3},{"organization":4,"armGroups":7,"interventions":41,"overallOfficials":47,"centralContacts":58,"locations":64,"responsibleParty":269,"collaborators":47,"id":271,"slug":272,"hasResults":273,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":47,"eligibilityCriteria":277,"healthyVolunteers":273,"sex":278,"minAge":279,"maxAge":47,"enrollmentInfo":280,"targetDuration":47,"studyType":283,"phases":284,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":67,"whyStopped":47,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},{"fullName":5,"class":6},"Vividion Therapeutics, Inc.","INDUSTRY",[8,14,19,24,28,32,36],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 (Dose Escalation): VVD-130037 Single Agent","EXPERIMENTAL","Participants will receive ascending doses of VVD-130037, orally, once or twice daily in 21-day treatment cycles during Part 1.",[13],"Drug: VVD-130037",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1 (Dose Escalation): VVD-130037 and Docetaxel Combination Therapy","Participants will receive ascending doses of VVD-130037, orally, once or twice daily along with docetaxel intravenous (IV) infusion administered once every 3 weeks in 21-day treatment cycles during Part 1.",[13,18],"Drug: Docetaxel",{"label":20,"type":10,"description":21,"interventionNames":22},"Part 1 (Dose Escalation): VVD-130037 and Paclitaxel Combination Therapy","Participants will receive ascending doses of VVD-130037, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 1.",[13,23],"Drug: Paclitaxel",{"label":25,"type":10,"description":26,"interventionNames":27},"Part 2 (Dose Expansion): VVD-130037 Single Agent","Participants will receive VVD-130037 at the recommended dose for expansion (RDE), orally, once or twice daily in 21-day treatment cycles during Part 2.",[13],{"label":29,"type":10,"description":30,"interventionNames":31},"Part 2 (Dose Expansion): VVD-130037 and Docetaxel Combination Therapy","Participants will receive VVD-130037 at the RDE, orally, once or twice daily along with docetaxel IV infusion administered once every 3 weeks in 21-day treatment cycles during Part 2.",[13,18],{"label":33,"type":10,"description":34,"interventionNames":35},"Part 2 (Dose Expansion): VVD-130037 and Paclitaxel Combination Therapy","Participants will receive VVD-130037 at the RDE, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 2.",[13,23],{"label":37,"type":10,"description":38,"interventionNames":39},"Experimental: Part 2 (Dose Expansion): VVD-130037 and Pembrolizumab Combination Therapy","Participants will first be evaluated in a safety-run in cohort to determine the RDE(s). Participants will then receive VVD-130037 at the RDE, orally, once or twice daily along with pembrolizumab IV infusion administered once every 3 weeks in 21-day treatment cycles during Part 2.",[13,40],"Drug: Pembrolizumab",[42,48,52,55],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","VVD-130037","Oral tablets",[37,9,15,20,25,29,33],null,{"type":43,"name":49,"description":50,"armGroupLabels":51,"otherNames":47},"Docetaxel","IV infusion",[15,29],{"type":43,"name":53,"description":50,"armGroupLabels":54,"otherNames":47},"Paclitaxel",[20,33],{"type":43,"name":56,"description":50,"armGroupLabels":57,"otherNames":47},"Pembrolizumab",[37],[59],{"name":60,"role":61,"phone":62,"phoneExt":47,"email":63},"Vividion Clinical Trial Call Center","CONTACT","(858) 345-9752","clinicaltrials@vividion.com",[65,79,88,97,107,117,127,136,146,155,164,172,180,188,193,198,203,210,220,225,233,238,243,248,253,261],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":47},"Mayo Clinic Jacksonville","RECRUITING","Jacksonville","Florida","32224","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-81.65565,30.33218,{"lat":77,"lon":76},{"facility":80,"status":67,"city":81,"state":69,"zip":82,"country":71,"countryCode":72,"cosmosGeoPoint":83,"geoPoint":87,"contacts":47},"Florida Cancer Specialists","Sarasota","34232",{"type":74,"coordinates":84},[85,86],-82.53065,27.33643,{"lat":86,"lon":85},{"facility":89,"status":67,"city":90,"state":69,"zip":91,"country":71,"countryCode":72,"cosmosGeoPoint":92,"geoPoint":96,"contacts":47},"Moffitt Cancer Center","Tampa","33612",{"type":74,"coordinates":93},[94,95],-82.45843,27.94752,{"lat":95,"lon":94},{"facility":98,"status":67,"city":99,"state":100,"zip":101,"country":71,"countryCode":72,"cosmosGeoPoint":102,"geoPoint":106,"contacts":47},"Mayo Clinic Rochester","Rochester","Minnesota","55905",{"type":74,"coordinates":103},[104,105],-92.4699,44.02163,{"lat":105,"lon":104},{"facility":108,"status":67,"city":109,"state":110,"zip":111,"country":71,"countryCode":72,"cosmosGeoPoint":112,"geoPoint":116,"contacts":47},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"type":74,"coordinates":113},[114,115],-86.78444,36.16589,{"lat":115,"lon":114},{"facility":118,"status":67,"city":119,"state":120,"zip":121,"country":71,"countryCode":72,"cosmosGeoPoint":122,"geoPoint":126,"contacts":47},"MDACC","Houston","Texas","77030",{"type":74,"coordinates":123},[124,125],-95.36327,29.76328,{"lat":125,"lon":124},{"facility":128,"status":67,"city":129,"state":120,"zip":130,"country":71,"countryCode":72,"cosmosGeoPoint":131,"geoPoint":135,"contacts":47},"NEXT Dallas","Irving","75039",{"type":74,"coordinates":132},[133,134],-96.94889,32.81402,{"lat":134,"lon":133},{"facility":137,"status":67,"city":138,"state":139,"zip":140,"country":71,"countryCode":72,"cosmosGeoPoint":141,"geoPoint":145,"contacts":47},"NEXT Virginia","Fairfax","Virginia","22031",{"type":74,"coordinates":142},[143,144],-77.30637,38.84622,{"lat":144,"lon":143},{"facility":147,"status":67,"city":148,"state":47,"zip":47,"country":149,"countryCode":47,"cosmosGeoPoint":150,"geoPoint":154,"contacts":47},"National Cancer Center","Goyang","South Korea",{"type":74,"coordinates":151},[152,153],127.19731,36.21689,{"lat":153,"lon":152},{"facility":156,"status":67,"city":148,"state":47,"zip":47,"country":149,"countryCode":47,"cosmosGeoPoint":157,"geoPoint":159,"contacts":160},"The Catholic University of Korea, St. Vincent's Hospital",{"type":74,"coordinates":158},[152,153],{"lat":153,"lon":152},[161],{"name":162,"role":61,"phone":163,"phoneExt":47,"email":47},"Vividion Call Center","+1 8583459752",{"facility":165,"status":67,"city":166,"state":47,"zip":47,"country":149,"countryCode":47,"cosmosGeoPoint":167,"geoPoint":171,"contacts":47},"Gachon University Gil Medical Center","Incheon",{"type":74,"coordinates":168},[169,170],126.70515,37.45646,{"lat":170,"lon":169},{"facility":173,"status":67,"city":174,"state":47,"zip":47,"country":149,"countryCode":47,"cosmosGeoPoint":175,"geoPoint":179,"contacts":47},"Seoul National University; Bundang Hospital","Seongnam",{"type":74,"coordinates":176},[177,178],127.7548,36.4052,{"lat":178,"lon":177},{"facility":181,"status":67,"city":182,"state":47,"zip":47,"country":149,"countryCode":47,"cosmosGeoPoint":183,"geoPoint":187,"contacts":47},"Asan Medical Center","Seoul",{"type":74,"coordinates":184},[185,186],126.9784,37.566,{"lat":186,"lon":185},{"facility":189,"status":67,"city":182,"state":47,"zip":47,"country":149,"countryCode":47,"cosmosGeoPoint":190,"geoPoint":192,"contacts":47},"Samsung Medical Center",{"type":74,"coordinates":191},[185,186],{"lat":186,"lon":185},{"facility":194,"status":67,"city":182,"state":47,"zip":47,"country":149,"countryCode":47,"cosmosGeoPoint":195,"geoPoint":197,"contacts":47},"Seoul National University Hospital",{"type":74,"coordinates":196},[185,186],{"lat":186,"lon":185},{"facility":199,"status":67,"city":182,"state":47,"zip":47,"country":149,"countryCode":47,"cosmosGeoPoint":200,"geoPoint":202,"contacts":47},"Severance Hospital; Yonsei University Health System",{"type":74,"coordinates":201},[185,186],{"lat":186,"lon":185},{"facility":156,"status":67,"city":204,"state":47,"zip":47,"country":149,"countryCode":47,"cosmosGeoPoint":205,"geoPoint":209,"contacts":47},"Suwon",{"type":74,"coordinates":206},[207,208],127.00889,37.29111,{"lat":208,"lon":207},{"facility":211,"status":67,"city":212,"state":47,"zip":47,"country":213,"countryCode":214,"cosmosGeoPoint":215,"geoPoint":219,"contacts":47},"Hospital Vall d'Hebron","Barcelona","Spain","ES",{"type":74,"coordinates":216},[217,218],2.15899,41.38879,{"lat":218,"lon":217},{"facility":221,"status":67,"city":212,"state":47,"zip":47,"country":213,"countryCode":214,"cosmosGeoPoint":222,"geoPoint":224,"contacts":47},"START Barcelona Hospital HM Nou Delfos",{"type":74,"coordinates":223},[217,218],{"lat":218,"lon":217},{"facility":226,"status":67,"city":227,"state":47,"zip":47,"country":213,"countryCode":214,"cosmosGeoPoint":228,"geoPoint":232,"contacts":47},"Hospital Universitario 12 de Octubre","Madrid",{"type":74,"coordinates":229},[230,231],-3.70256,40.4165,{"lat":231,"lon":230},{"facility":234,"status":67,"city":227,"state":47,"zip":47,"country":213,"countryCode":214,"cosmosGeoPoint":235,"geoPoint":237,"contacts":47},"Hospital Universitario Ramon y Cajal",{"type":74,"coordinates":236},[230,231],{"lat":231,"lon":230},{"facility":239,"status":67,"city":227,"state":47,"zip":47,"country":213,"countryCode":214,"cosmosGeoPoint":240,"geoPoint":242,"contacts":47},"NEXT Madrid",{"type":74,"coordinates":241},[230,231],{"lat":231,"lon":230},{"facility":244,"status":67,"city":227,"state":47,"zip":47,"country":213,"countryCode":214,"cosmosGeoPoint":245,"geoPoint":247,"contacts":47},"START Madrid CIOCC",{"type":74,"coordinates":246},[230,231],{"lat":231,"lon":230},{"facility":249,"status":67,"city":227,"state":47,"zip":47,"country":213,"countryCode":214,"cosmosGeoPoint":250,"geoPoint":252,"contacts":47},"Start Madrid-FJD, Hospital Fundacion Jimenez Diaz",{"type":74,"coordinates":251},[230,231],{"lat":231,"lon":230},{"facility":254,"status":67,"city":255,"state":47,"zip":47,"country":213,"countryCode":214,"cosmosGeoPoint":256,"geoPoint":260,"contacts":47},"Clinica Universitaria de Navarra","Pamplona",{"type":74,"coordinates":257},[258,259],-1.64323,42.81687,{"lat":259,"lon":258},{"facility":262,"status":67,"city":263,"state":47,"zip":47,"country":213,"countryCode":214,"cosmosGeoPoint":264,"geoPoint":268,"contacts":47},"Hospital Clinico Universitario de Valencia","Valencia",{"type":74,"coordinates":265},[266,267],-0.37966,39.47391,{"lat":267,"lon":266},{"type":270,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100512581","phase-1-a-first-in-human-fih-study-to-evaluate-the-safety-and-tolerability-of-vvd-130037-in-participants-with-advanced-solid-tumors-100512581",false,"NCT05954312","A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors","A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of VVD-130037, a Kelch-like ECH Associated Protein 1 (KEAP1) Activator, in Participants With Advanced Solid Tumors","Key Inclusion Criteria for Parts 1 and 2:\n\n* Histologically or cytologically confirmed metastatic or unresectable solid tumor.\n* Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the Investigator.\n* Have progressed on or after all prior standard-of-care therapies for metastatic disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Adequate organ and marrow function as defined in the protocol.\n\nAdditional Key Inclusion Criteria for Part 2:\n\n* Participants with squamous non-small cell lung cancer (sqNSCLC) with or without nuclear factor erythroid 2-related factor 2 (NRF2 \\[NFE2L2\\]) and\u002For cullin 3 (CUL3) mutations.\n* Participants with advanced sqNSCLC must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor.\n* Participants with advanced head and neck squamous cell carcinoma (HNSCC) must have received prior treatment with platinum-based chemotherapy, an immune checkpoint inhibitor (for tumors with known programmed death-ligand 1 \\[PD-L1\\] expression, microsatellite instability-high, or mismatch repair deficiency, and an anti-epidermal growth factor receptor agent) (Combination Expansion Cohort).\n* Participants with advanced esophageal squamous cell carcinoma (ESCC) must have received prior treatment with platinum-based chemotherapy, an immune checkpoint inhibitor (for tumors with known PD-L1 expression) (Combination Expansion Cohort).\n* Participants with a known driver mutation, including activating epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, should have progressed after appropriate targeted treatment.\n* Participants with known human epidermal growth factor receptor 2 overexpression should have progressed after appropriate targeted treatment.\n\nKey Exclusion Criteria for Parts 1 and 2:\n\n* Participant is known to have a mutation that has no expectation of benefit from VVD-130037. Current such mutations include the following:\n\n  1. KEAP1 nonsense mutation (any position)\n  2. KEAP1 frameshift mutation (any position)\n* Any unresolved toxicity Grade ≥2 per CTCAE version 5.0 from previous anticancer treatment.\n* Current or prior treatment with anti-epileptic medications for the treatment or prophylaxis of seizures.\n* History of seizure or condition that may predispose to seizure.\n* History or presence of central nervous system (CNS) metastases or spinal cord compression.\n* Uncontrolled arterial hypertension despite optimal medical management.\n* Risk factors for abnormal heart rhythm\u002FQT prolongation as defined in the protocol.\n* History of the following cardiac diseases:\n\n  i) congestive heart failure (New York Heart Association \\[NYHA\\] Class \\>II), ii) unstable angina, iii) new onset angina within past 6 months, iv) myocardial Infarction within the past 6 months, v) clinically significant arrhythmias within past 6 months.\n* Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation (Combination Expansion Cohort)\n* Medical history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD), drug induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active pneumonitis\u002FILD (Combination Expansion Cohort)","ALL","18 Years",{"count":281,"type":282},290,"ESTIMATED","INTERVENTIONAL",[285],"PHASE1","A FIH dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab.",[288],"Advanced Solid Tumors",[44,290,291,292,293,294,295,296],"First-in-Human","KEAP1","NRF2","Cancer","small molecule","squamous cell histology","esophageal adenocarcinoma","2026-05-06",{"date":299,"type":300},"2026-05-08","ACTUAL",{"date":302,"type":300},"2023-07-28",{"date":304,"type":282},"2031-02-28",{"name":5,"class":6},26]