[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618630":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":47,"responsibleParty":157,"collaborators":159,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":41,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":41,"enrollmentInfo":172,"targetDuration":41,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":50,"whyStopped":41,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"Myeloid Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MT-304 Monotherapy","EXPERIMENTAL","Participants receive MT-304 administered intravenously once every 14 days (Q14D) in escalating dose levels.",[13],"Drug: MT-304",{"label":15,"type":10,"description":16,"interventionNames":17},"MT-304 + Nivolumab Combination Therapy","Participants receive MT-304 administered intravenously once every 14 days (Q14D) in combination with nivolumab as \"per local label\" administered once every 28 days (Q28D).",[18],"Drug: MT-304 + Nivolumab",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","MT-304","Safety, tolerability, and pharmacokinetics will be evaluated.",[9],[26],"mRNA-LNP",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"MT-304 + Nivolumab","Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.",[15],[26],[33],{"name":34,"affiliation":5,"role":35},"Matthew Maurer, MD","STUDY_DIRECTOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Project 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Brisbane","Queensland","4101",{"type":57,"coordinates":103},[104,105],153.02049,-27.48034,{"lat":105,"lon":104},[108,111],{"name":109,"role":39,"phone":110,"phoneExt":41,"email":41},"A\u002FProf Jermaine Coward","+61737374500",{"name":109,"role":67,"phone":41,"phoneExt":41,"email":41},{"facility":113,"status":50,"city":114,"state":115,"zip":116,"country":54,"countryCode":55,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Cancer Research SA Pty Ltd","Adelaide","South Australia","5000",{"type":57,"coordinates":118},[119,120],138.59863,-34.92866,{"lat":120,"lon":119},[123,126],{"name":124,"role":39,"phone":125,"phoneExt":41,"email":41},"Dr Meena Okera","+61883592565",{"name":124,"role":67,"phone":41,"phoneExt":41,"email":41},{"facility":128,"status":50,"city":129,"state":130,"zip":131,"country":54,"countryCode":55,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Cabrini Health","Melbourne","Victoria","3144",{"type":57,"coordinates":133},[134,135],144.96332,-37.814,{"lat":135,"lon":134},[138,141],{"name":139,"role":39,"phone":140,"phoneExt":41,"email":41},"Dr. Prachi Bhave","+61395083437",{"name":139,"role":67,"phone":41,"phoneExt":41,"email":41},{"facility":143,"status":50,"city":144,"state":145,"zip":146,"country":54,"countryCode":55,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Linear Clinical Research","Nedlands","Western Australia","6009",{"type":57,"coordinates":148},[149,150],115.8073,-31.98184,{"lat":150,"lon":149},[153,156],{"name":154,"role":39,"phone":155,"phoneExt":41,"email":41},"Dr Timothy Humphries","+61863825100",{"name":154,"role":67,"phone":41,"phoneExt":41,"email":41},{"type":158,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[160],{"name":161,"class":162},"CREATE Medicines","UNKNOWN","100618630","phase-1-safety-pharmacokinetics-pharmacodynamics-and-preliminary-efficacy-of-mt-304-in-adults-with-advanced-her2-expressing-solid-tumors-100618630",false,"NCT07334119","Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors","A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors","Inclusion Criteria:\n\n* Aged 18 years or above\n* Histologically confirmed diagnosis of metastatic or advanced epithelial cancer expressing HER2 (Note: Participants with other tumor types expressing HER2 may be considered pending discussion with the Medical Monitor).\n* Measurable lesion per RECIST 1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1.\n* Adequate Organ function\n\nExclusion Criteria:\n\n* Known active CNS metastasis and\u002For carcinomatous meningitis.\n* Any acute illness including fever.\n* History of symptomatic congestive heart failure\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites\n* Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year.","ALL","18 Years",{"count":173,"type":174},60,"ESTIMATED","INTERVENTIONAL",[177],"PHASE1","This clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-304 in adults with advanced HER2-expressing solid tumors. The main questions it aims to answer are:\n\n* What is the safety profile of MT-304 when administered alone or with nivolumab?\n* What is the recommended Phase 2 dose (RP2D) of MT-304?\n\nParticipants will:\n\n* Receive MT-304 alone (every 14 days) or with nivolumab (every 28 days).\n* Attend regular clinic visits for assessments and monitoring.\n* Continue treatment until disease progression, unacceptable toxicity, or study discontinuation.",[180],"HER2-Expressing Solid Tumors",[182,183,184,185,186,187,188,189,190,191,192,193,194],"Anti-HER2 chimeric antigen receptor","Chimeric Antigen Receptor (CAR)","mRNA","Lipid nanoparticle (LNP)","Urothelial carcinoma","Endometrial carcinoma","Ovarian epithelial carcinoma","Breast carcinoma (all subtypes)","Gastric adenocarcinoma","Esophageal adenocarcinoma","Non-small cell lung cancer","Colorectal carcinoma","Biliary cancer (including Gallbladder carcinoma and extrahepatic cholangiocarcinoma)","2026-05-18",{"date":197,"type":198},"2026-05-20","ACTUAL",{"date":200,"type":198},"2025-11-25",{"date":202,"type":174},"2028-03-30",{"name":5,"class":6},7]