[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552869":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":67,"studyPopulation":30,"armGroups":68,"interventions":80,"overallOfficials":88,"centralContacts":92,"locations":102,"responsibleParty":214,"collaborators":216,"id":220,"slug":30,"hasResults":221,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":30,"eligibilityCriteria":225,"healthyVolunteers":221,"sex":226,"minAge":227,"maxAge":30,"enrollmentInfo":228,"targetDuration":30,"studyType":231,"phases":232,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":105,"whyStopped":30,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},{"fullName":5,"class":6},"Myeloid Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":30},[9,13,17,21,25,28],{"measure":10,"description":11,"timeFrame":12},"Type, incidence and severity of Adverse Events","Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0","Up to 2 years from the last dose of Investigational Medicinal Product (IMP)",{"measure":14,"description":15,"timeFrame":16},"Recommended Phase 2 Dose (RP2D)","The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data","28 days from the last dose of IMP",{"measure":18,"description":19,"timeFrame":20},"Optimal Biological dose (OBD)","The OBD will be determined using dose limiting toxicities (DLTs) and all other available study data","21 days from the last dose of IMP",{"measure":22,"description":23,"timeFrame":24},"Change from baseline in vital signs","Temperature, weight, height, pulse rate and blood pressure will be assessed","Up to 30 days from the last dose of IMP",{"measure":26,"description":27,"timeFrame":24},"Change in laboratory parameters","Hematology, chemistry, coagulation, virology and urine analysis will be assessed.",{"measure":29,"description":30,"timeFrame":31},"Change from baseline in ECG parameters",null,"Screening, Day 1 and Day 15",[33,37,39,41,43,45,47,49,52,55,57,59],{"measure":34,"description":35,"timeFrame":36},"Pharmacokinetics (PK)","PK parameter: Plasma concentrations","Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.",{"measure":34,"description":38,"timeFrame":36},"PK parameter: Area under Curve",{"measure":34,"description":40,"timeFrame":36},"PK parameter: Time of maximum observed plasma concentration (tmax)",{"measure":34,"description":42,"timeFrame":36},"PK parameter: Plasma Clearance (CL)",{"measure":34,"description":44,"timeFrame":36},"PK parameter: Volume of Distribution (Vd)",{"measure":34,"description":46,"timeFrame":36},"PK parameter: Mean residence time (MRT)",{"measure":34,"description":48,"timeFrame":36},"PK parameter: terminal rate constant (λz)",{"measure":50,"description":30,"timeFrame":51},"To assess adverse events of special interest (AESI) by measuring infusion reaction","upto 2 years from the last dose of IMP",{"measure":53,"description":30,"timeFrame":54},"To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)","Up to 2 years from the last dose of IMP",{"measure":56,"description":30,"timeFrame":54},"To assess adverse events of special interest (AESI) by measuring immune effector cell-associated neurotoxicity syndrome (ICANS)",{"measure":58,"description":30,"timeFrame":54},"To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction",{"measure":60,"description":30,"timeFrame":51},"To assess adverse events of special interest (AESI) by checking for second primary malignancy",{"allocation":62,"interventionModel":63,"interventionModelDescription":30,"primaryPurpose":64,"observationalModel":30,"timePerspective":30,"maskingInfo":65},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":66,"maskingDescription":30,"whoMasked":30},"NONE","Participants will be enrolled into one of two treatment modules:\n\n* Module 1 (Monotherapy): Participants will receive MT-303.\n* Module 2 (Combination therapy): Participants will receive MT-303 in combination with atezolizumab + bevacizumab (Atezo\u002FBev).\n\nIn Module 1 (Monotherapy), participants will receive MT-303 across five dose-escalation cohorts and in Module 2 (Combination therapy), participants will receive MT-303 in combination with Atezo\u002FBev across five dose-escalation cohorts.\n\nAdditional cohorts in both modules may be scheduled based on emerging safety and PK data.\n\nParticipants will be sequentially enrolled into Cohorts 1 through 5. Both modules will be enrolled concurrently, with Module 2 dosing beginning at one dose level below the known safe dose in Module 1. Safety Review Committee decisions will be informed by all available safety data from Modules 1 and 2.",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"MT-303","EXPERIMENTAL","Participants will receive MT-303 through intravenous infusion.",[74],"Drug: MT-303",{"label":76,"type":71,"description":77,"interventionNames":78},"MT-303 + Atezolizumab + Bevacizumab","Participants will receive MT-303 in combination with Atezo\u002FBev through intravenous infusion.",[79],"Drug: MT-303 +Atezolizumab + Bevacizumab",[81,84],{"type":82,"name":70,"description":70,"armGroupLabels":83,"otherNames":30},"DRUG",[70],{"type":82,"name":85,"description":86,"armGroupLabels":87,"otherNames":30},"MT-303 +Atezolizumab + Bevacizumab","MT-303 in combination with Atezo\u002FBev",[76],[89],{"name":90,"affiliation":5,"role":91},"Matthew Maurer, MD","STUDY_DIRECTOR",[93,98],{"name":94,"role":95,"phone":96,"phoneExt":30,"email":97},"Project Manager","CONTACT","+61 2 8569 1400","Lucy.FrereScott@novotech-cro.com",{"name":99,"role":95,"phone":100,"phoneExt":30,"email":101},"Clinical Department","+1 617 465 1022","303clinical@myeloidtx.com",[103,120,133,146,159,171,182,193,206],{"facility":104,"status":105,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"St Vincent's Hospital","RECRUITING","Sydney","New South Wales","2010","Australia","AU",{"type":112,"coordinates":113},"Point",[114,115],151.20732,-33.86785,{"lat":115,"lon":114},[118],{"name":119,"role":95,"phone":30,"phoneExt":30,"email":30},"Hao-Wen Sim, MD",{"facility":121,"status":105,"city":122,"state":123,"zip":124,"country":109,"countryCode":110,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Integrated Clinical Oncology Network (ICON) Pty Ltd","Woolloongabba","Queensland","4102",{"type":112,"coordinates":126},[127,128],153.03655,-27.48855,{"lat":128,"lon":127},[131],{"name":132,"role":95,"phone":30,"phoneExt":30,"email":30},"Vladimir Andelkovic, MD",{"facility":134,"status":105,"city":135,"state":136,"zip":137,"country":109,"countryCode":110,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"The Alfred Hospital","Melbourne","Victoria","3004",{"type":112,"coordinates":139},[140,141],144.96332,-37.814,{"lat":141,"lon":140},[144],{"name":145,"role":95,"phone":30,"phoneExt":30,"email":30},"Stuart Roberts, MD",{"facility":147,"status":105,"city":148,"state":149,"zip":150,"country":109,"countryCode":110,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Linear Clinical Research","Murdoch","Western Australia","6150",{"type":112,"coordinates":152},[153,154],115.83757,-32.06987,{"lat":154,"lon":153},[157],{"name":158,"role":95,"phone":30,"phoneExt":30,"email":30},"Tim Humphries, MD",{"facility":160,"status":105,"city":161,"state":30,"zip":30,"country":162,"countryCode":30,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Pusan National Univesity Hospital","Busan","South Korea",{"type":112,"coordinates":164},[165,166],129.03004,35.10168,{"lat":166,"lon":165},[169],{"name":170,"role":95,"phone":30,"phoneExt":30,"email":30},"Jeong Heo, MD",{"facility":172,"status":105,"city":173,"state":30,"zip":30,"country":162,"countryCode":30,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Cha University Bundang Medical Center","Gyeonggi-do",{"type":112,"coordinates":175},[176,177],126.76917,37.58944,{"lat":177,"lon":176},[180],{"name":181,"role":95,"phone":30,"phoneExt":30,"email":30},"Hongjae Jeoon, MD",{"facility":183,"status":105,"city":184,"state":30,"zip":30,"country":162,"countryCode":30,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Seoul National University Hospital","Seoul",{"type":112,"coordinates":186},[187,188],126.9784,37.566,{"lat":188,"lon":187},[191],{"name":192,"role":95,"phone":30,"phoneExt":30,"email":30},"Yoon Jun Kim, MD",{"facility":194,"status":105,"city":195,"state":30,"zip":30,"country":196,"countryCode":197,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"National Taiwan University Hospital","Taipei","Taiwan","TW",{"type":112,"coordinates":199},[200,201],121.52639,25.05306,{"lat":201,"lon":200},[204],{"name":205,"role":95,"phone":30,"phoneExt":30,"email":30},"Chih-hung Hsu",{"facility":207,"status":105,"city":195,"state":30,"zip":30,"country":196,"countryCode":197,"cosmosGeoPoint":208,"geoPoint":210,"contacts":211},"Taipei Tzu Chi Hospital",{"type":112,"coordinates":209},[200,201],{"lat":201,"lon":200},[212],{"name":213,"role":95,"phone":30,"phoneExt":30,"email":30},"Her-shyong Shiah",{"type":215,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[217],{"name":218,"class":219},"CREATE Medicines","UNKNOWN","100552869",false,"NCT06478693","A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC","A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including Hepatocellular Carcinoma","Inclusion Criteria\n\n* Aged 18 years or older\n* Histological diagnosis of advanced\u002Frecurrent or metastatic and\u002For unresectable HCC. \\[Note: participants with other tumor types expressing GPC3 may be eligible for Module 1 pending a discussion with the Medical Monitor. Only participants with HCC are eligible for Module 2.\n* Measurable lesion per RECIST 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1\n* Child-Pugh score: Class A\n* Adequate organ function\n\nGeneral Exclusion Criteria\n\n* Known active CNS metastasis and\u002For carcinomatous meningitis.\n* Any acute illness including active infection\n* History of liver transplantation or on waiting list\n* Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding\n* Uncontrolled pleural effusion, pericardial effusion, or ascites\n* History of symptomatic congestive heart failure\n* History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.\n\nAdditional Module 2 Exclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Significant cardiovascular disease\n* History of severe hypersensitivity to atezolizumab and\u002For bevacizumab.\n* History of idiopathic pulmonary fibrosis\n* Prior history of hypertensive crisis or hypertensive encephalopathy.","ALL","18 Years",{"count":229,"type":230},70,"ESTIMATED","INTERVENTIONAL",[233],"PHASE1","This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability and define the RP2D of MT-303 alone (Module 1) and in combination with Atezo\u002FBev (Module 2) in participants with advanced hepatocellular carcinoma expressing GPC3.",[236],"Hepatocellular Carcinoma",[238,239,240,241,242],"Liver Cancer","Hepatocellular Carcinoma (HCC)","Glypican-3","Chimeric antigen receptor","CAR-M","2025-12-11",{"date":245,"type":246},"2025-12-18","ACTUAL",{"date":248,"type":246},"2024-07-01",{"date":250,"type":230},"2028-05-31",{"name":5,"class":6},9]