[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413562":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":44,"centralContacts":49,"locations":58,"responsibleParty":202,"collaborators":31,"id":204,"slug":205,"hasResults":206,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":31,"eligibilityCriteria":210,"healthyVolunteers":206,"sex":211,"minAge":212,"maxAge":31,"enrollmentInfo":213,"targetDuration":31,"studyType":216,"phases":217,"briefSummary":220,"conditions":221,"keywords":31,"overallStatus":61,"whyStopped":31,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},{"fullName":5,"class":6},"Vivace Therapeutics, Inc","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"VT3989 Dose Escalation [Not Recruiting]","EXPERIMENTAL","VT3989 dosed orally in 21 or 28 day cycles. Patients will be enrolled into escalating dose levels during the Dose Escalation Phase",[13],"Drug: VT3989",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion [Not Recruiting]","VT3989 dosed in 21 or 28 day cycles in patients with refractory metastatic solid tumors or mesothelioma.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Combination [Recruiting]","For Cohort A and B, VT3989 dosed in 28 day cycles in patients with metastatic solid tumors or mesothelioma, in combination with immunotherapy (nivolumab\u002Fipilimumab) or targeted therapy (osimertinib). For Cohort C, VT3989 dosed in 21 day cycles in patients with mesothelioma in combination with chemotherapy (pemetrexed+carboplatin) for 4-6 cycles, then continuing VT3989 as monotherapy on 28-day cycle.",[13,22,23,24],"Drug: Nivolumab & Ipilimumab","Drug: Osimertinib","Drug: Pemetrexed\u002FCarboplatin",[26,32,36,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","VT3989","25, 50, 100, 150 or 200 mg capsules for oral administration.",[19,15,9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Nivolumab & Ipilimumab","Nivolumab infusion - 360 mg every 3 weeks, 30-minute intravenous infusion\n\nIpilimumab infusion - 1 mg\u002Fkg every 6 weeks, 30-minute intravenous infusion",[19],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Osimertinib","40 or 80 mg tablets for oral administration",[19],{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"Pemetrexed\u002FCarboplatin","Pemetrexed infusion: 500 mg\u002Fm2 intravenous infusion Carboplatin infusion: AUC 5.0 intravenous infusion",[19],[45],{"name":46,"affiliation":47,"role":48},"Neelesh Sharma, MD","Vivace Therapeutics","STUDY_DIRECTOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},"Heather Fritz","CONTACT","650-627-7437","hfritz@inclin.com",{"name":46,"role":52,"phone":56,"phoneExt":31,"email":57},"732-476-4978","nsharma@vivacetherapeutics.com",[59,75,87,99,107,119,130,142,153,165,179,190],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"UCSF Helen Diller Family Comprehensive Cancer Center","RECRUITING","San Francisco","California","94158","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-122.41942,37.77493,{"lat":71,"lon":70},[74],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":76,"status":61,"city":77,"state":78,"zip":79,"country":65,"countryCode":66,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"University of Chicago Medical Center","Chicago","Illinois","60637",{"type":68,"coordinates":81},[82,83],-87.65005,41.85003,{"lat":83,"lon":82},[86],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":88,"status":61,"city":89,"state":90,"zip":91,"country":65,"countryCode":66,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":68,"coordinates":93},[94,95],-71.05977,42.35843,{"lat":95,"lon":94},[98],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":100,"status":61,"city":89,"state":90,"zip":101,"country":65,"countryCode":66,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"Dana-Farber Cancer Institute","02215",{"type":68,"coordinates":103},[94,95],{"lat":95,"lon":94},[106],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":108,"status":61,"city":109,"state":110,"zip":111,"country":65,"countryCode":66,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"M Health Fairview University of Minnesota Medical Center","Minneapolis","Minnesota","55455",{"type":68,"coordinates":113},[114,115],-93.26384,44.97997,{"lat":115,"lon":114},[118],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":120,"status":61,"city":121,"state":121,"zip":122,"country":65,"countryCode":66,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Memorial Sloan Kettering Cancer Center","New York","10065",{"type":68,"coordinates":124},[125,126],-74.00597,40.71427,{"lat":126,"lon":125},[129],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":131,"status":61,"city":132,"state":133,"zip":134,"country":65,"countryCode":66,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":68,"coordinates":136},[137,138],-95.36327,29.76328,{"lat":138,"lon":137},[141],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":143,"status":61,"city":144,"state":133,"zip":145,"country":65,"countryCode":66,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"NEXT Oncology","San Antonio","78229",{"type":68,"coordinates":147},[148,149],-98.49363,29.42412,{"lat":149,"lon":148},[152],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":154,"status":61,"city":155,"state":156,"zip":157,"country":65,"countryCode":66,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Virginia Cancer Specialists, PC","Arlington","Virginia","22201",{"type":68,"coordinates":159},[160,161],-77.10428,38.88101,{"lat":161,"lon":160},[164],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":166,"status":61,"city":167,"state":168,"zip":169,"country":170,"countryCode":171,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Monash Health","Clayton","Victoria","3168","Australia","AU",{"type":68,"coordinates":173},[174,175],145.11667,-37.91667,{"lat":175,"lon":174},[178],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":180,"status":61,"city":181,"state":168,"zip":182,"country":170,"countryCode":171,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Peter MacCullum Cancer Centre","Melbourne","3000",{"type":68,"coordinates":184},[185,186],144.96332,-37.814,{"lat":186,"lon":185},[189],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"facility":191,"status":61,"city":192,"state":193,"zip":194,"country":170,"countryCode":171,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Linear Clinical Research","Nedlands","Western Australia","6009",{"type":68,"coordinates":196},[197,198],115.8073,-31.98184,{"lat":198,"lon":197},[201],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"type":203,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100413562","phase-1-study-to-evaluate-vt3989-in-patients-with-metastatic-solid-tumors-100413562",false,"NCT04665206","Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors","Phase I\u002FII, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Part 3 Combination Cohort A: Patients with pathologically diagnosed, metastatic or unresectable malignant mesothelioma (including both pleural and non-pleural) who have not received systemic therapy.\n* Part 3 Combination Cohort B: Patients with pathologically diagnosed incurable locally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19 deletions or exon 21 L858R mutations, with or without prior treatment with Osimertinib.\n* Part 3 Combination Cohort C: Patients with pathologically diagnosed metastatic or unresectable malignant pleural mesothelioma who have not received systemic chemotherapy.\n* Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solid tumors or modified RECIST v1.1 for malignant pleural mesothelioma. mRECIST may be used for pleural extension of non-pleural mesothelioma or for mixed pleural and peritoneal (or other) mesothelioma.\n* ECOG: 0-1.\n* Adequate organ functions, including the liver, kidneys, and hematopoietic system.\n\nExclusion Criteria:\n\n* Active brain metastases or primary CNS (central nervous system) tumors.\n* History of leptomeningeal metastases\n* Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy\n* Known HIV positive or active Hepatitis B or Hepatitis C\n* Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents.\n* Corrected QT (QTcF) interval \\> 470 msec (using Fridericia's correction formula).\n* Additional active malignancy that may confound the assessment of the study endpoints\n* Women who are pregnant or breastfeeding\n* Prior treatment with TEAD inhibitor.","ALL","18 Years",{"count":214,"type":215},434,"ESTIMATED","INTERVENTIONAL",[218,219],"PHASE1","PHASE2","This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered, alone or in combination, once daily in patients with mesothelioma and\u002For metastatic solid tumors that are resistant to standard therapy or for which no effective standard therapy is available.",[222,223,224],"Solid Tumor, Adult","Mesothelioma","NSCLC","2026-03-27",{"date":227,"type":228},"2026-04-02","ACTUAL",{"date":230,"type":228},"2021-03-24",{"date":232,"type":215},"2030-03-02",{"name":5,"class":6},12]