[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550264":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":38,"locations":46,"responsibleParty":155,"collaborators":33,"id":157,"slug":33,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":158,"sex":164,"minAge":165,"maxAge":33,"enrollmentInfo":166,"targetDuration":33,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":33,"overallStatus":49,"whyStopped":33,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"KaliVir Immunotherapeutics","INDUSTRY",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: VET3-TGI alone intratumoral","EXPERIMENTAL","Dose escalation of VET3-TGI alone administered by direct injection into tumor(s) x 4. Booster injections of VET3-TGI are permitted for up to 2 years.",[13],"Drug: VET3-TGI",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B: VET3-TGI intratumoral in combination with atezolizumab","VET3-TGI will be given in combination with atezolizumab at the highest tolerated dose from Group A. Atezolizumab will be administered via intravenous (IV) infusion for up to 2 years.",[13,18],"Drug: Atezolizumab",{"label":20,"type":10,"description":21,"interventionNames":22},"Group C: VET3-TGI alone intravenous","Dose escalation of VET3-TGI alone administered by IV infusion x 6. Booster infusions of VET3-TGI are permitted for up to 2 years.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Group D: VET3-TGI intravenous in combination with atezolizumab","VET3-TGI will be given in combination with atezolizumab at the highest tolerated dose from Group C. Atezolizumab will be administered via intravenous (IV) infusion for up to 2 years.",[13,18],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","VET3-TGI","Oncolytic vaccinia virus engineered with immunomodulatory transgenes",[9,15,20,24],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Atezolizumab","anti-pd-L1 antibody",[15,24],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},"Adina Pelusio","CONTACT","+13057722084","clinops@kalivir.com",{"name":45,"role":41,"phone":33,"phoneExt":33,"email":43},"James Burke, MD",[47,67,81,96,111,125,141],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"USC\u002FNorris Comprehensive Cancer Center","RECRUITING","Los Angeles","California","90033","United States",{"type":55,"coordinates":56},"Point",[57,58],-118.24368,34.05223,{"lat":58,"lon":57},[61,64],{"name":62,"role":41,"phone":33,"phoneExt":33,"email":63},"Xiomara Menendez, RN","Xiomara.Menendez@med.usc.edu",{"name":65,"role":66,"phone":33,"phoneExt":33,"email":33},"Jacob Thomas, MD","PRINCIPAL_INVESTIGATOR",{"facility":68,"status":49,"city":69,"state":51,"zip":70,"country":53,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"UC Irvine Health","Orange","92868",{"type":55,"coordinates":72},[73,74],-117.85311,33.78779,{"lat":74,"lon":73},[77,79],{"name":78,"role":41,"phone":33,"phoneExt":33,"email":43},"Patient Contact",{"name":80,"role":66,"phone":33,"phoneExt":33,"email":33},"Edward Uchio, MD",{"facility":82,"status":49,"city":83,"state":84,"zip":85,"country":53,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"University of Miami","Miami","Florida","33136",{"type":55,"coordinates":87},[88,89],-80.19366,25.77427,{"lat":89,"lon":88},[92,94],{"name":93,"role":41,"phone":33,"phoneExt":33,"email":43},"Patient contact",{"name":95,"role":66,"phone":33,"phoneExt":33,"email":33},"Jaime Merchan, MD",{"facility":97,"status":49,"city":98,"state":99,"zip":100,"country":53,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Community Health Network","Indianapolis","Indiana","46250",{"type":55,"coordinates":102},[103,104],-86.15804,39.76838,{"lat":104,"lon":103},[107,109],{"name":78,"role":41,"phone":108,"phoneExt":33,"email":33},"317-621-2627",{"name":110,"role":66,"phone":33,"phoneExt":33,"email":33},"Bert O'Neil, MD",{"facility":112,"status":49,"city":113,"state":114,"zip":115,"country":53,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"UPMC- Hillman Cancer Center","Pittsburgh","Pennsylvania","15232",{"type":55,"coordinates":117},[118,119],-79.99589,40.44062,{"lat":119,"lon":118},[122,123],{"name":78,"role":41,"phone":33,"phoneExt":33,"email":43},{"name":124,"role":66,"phone":33,"phoneExt":33,"email":33},"Yana Najjar, MD",{"facility":126,"status":49,"city":127,"state":128,"zip":129,"country":53,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Mary Crowley Cancer Research","Dallas","Texas","75230",{"type":55,"coordinates":131},[132,133],-96.80667,32.78306,{"lat":133,"lon":132},[136,140],{"name":137,"role":41,"phone":138,"phoneExt":33,"email":139},"Minal Barve, MD","972-566-3000","referral@marycrowley.org",{"name":137,"role":66,"phone":33,"phoneExt":33,"email":33},{"facility":142,"status":49,"city":143,"state":128,"zip":144,"country":53,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"University of Texas MD Anderson Cancer Center","Houston","77030",{"type":55,"coordinates":146},[147,148],-95.36327,29.76328,{"lat":148,"lon":147},[151,153],{"name":93,"role":41,"phone":33,"phoneExt":33,"email":152},"ClinOps@KaliVir.com",{"name":154,"role":66,"phone":33,"phoneExt":33,"email":33},"Siqing Fu, MD, PhD",{"type":156,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100550264",false,"NCT06444815","A Study of VET3-TGI in Patients With Solid Tumors","A Phase 1\u002F1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors","STEALTH-001","Key Inclusion Criteria:\n\n* Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.\n* Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab\u002FPDL1 antibodies), and chemotherapy\n* Measurable disease as per RECIST 1.1 criteria\n* At least one tumor amenable to safe ITu injections and\u002For biopsies\n* ECOG performance status 0 or 1\n* Demonstrate adequate organ function\n* Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions\n\nAdditional Inclusion criteria exist\n\nKey Exclusion Criteria:\n\n* Prior systemic therapy washout (dependent upon the therapy)\n* Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.\n* CNS metastases and\u002For carcinomatous meningitis that have not been completely resected or completely irradiated.\n* Prior history of myocarditis\n* Known HIV\u002FAIDS, active HBV or HCV infection.\n* Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).\n\nAdditional Exclusion criteria exist","ALL","18 Years",{"count":167,"type":168},60,"ESTIMATED","INTERVENTIONAL",[171],"PHASE1","VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).",[174,175,176,177,178,179,180,181,182,183,184,185,186],"Solid Tumor, Adult","Microsatellite Stable Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Cervical Cancer","Kidney Cancer","Renal Cell Carcinoma","Melanoma Stage IV","Merkel Cell Carcinoma of Skin","Mesothelioma","Non-small Cell Lung Cancer","Cutaneous Squamous Cell Carcinoma (CSCC)","Urothelial Carcinoma Bladder","Squamous Cell Carcinoma","2026-04-01",{"date":189,"type":190},"2026-04-07","ACTUAL",{"date":192,"type":190},"2024-09-16",{"date":194,"type":168},"2027-12-31",{"name":5,"class":6},7]