[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618630":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":67,"studyPopulation":50,"armGroups":68,"interventions":80,"overallOfficials":93,"centralContacts":97,"locations":107,"responsibleParty":217,"collaborators":219,"id":223,"slug":50,"hasResults":224,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":50,"eligibilityCriteria":228,"healthyVolunteers":224,"sex":229,"minAge":230,"maxAge":50,"enrollmentInfo":231,"targetDuration":50,"studyType":234,"phases":235,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":110,"whyStopped":50,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},{"fullName":5,"class":6},"Myeloid Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":50},[9,13,17,20,24,28],{"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.","Up to 90 days from the last dose of Investigational Medicinal Product (IMP)",{"measure":14,"description":15,"timeFrame":16},"Number of Participants With Change From Baseline in Vital Signs (Composite Safety Outcome)","Body temperature, body weight, pulse rate, and blood pressure (systolic and diastolic) assessed collectively; participants with clinically significant changes in any vital sign parameter will be summarized as a composite safety outcome.","Up to 30 days from the last dose of IMP",{"measure":18,"description":19,"timeFrame":16},"Number of Participants With Abnormal Clinical Laboratory Parameters (Composite Safety Outcome)","Hematology, clinical chemistry, coagulation, virology testing, and urinalysis assessed collectively; participants with abnormalities in any laboratory parameter will be summarized as a composite safety outcome.",{"measure":21,"description":22,"timeFrame":23},"Number of Participants With Change From Baseline in ECG Parameters (Composite Safety Outcome)","PR interval, QRS duration, QT interval, corrected QT interval (QTc), and heart rate assessed collectively from 12-lead ECG recordings; participants with clinically significant changes in any ECG parameter will be summarized as a composite safety outcome.","Screening through Day 28, with assessments performed on Screening, Day 1 (pre-dose), and Day 28.",{"measure":25,"description":26,"timeFrame":27},"Maximum Tolerated Dose (MTD)","The MTD in Module 1 (monotherapy) will be determined based on dose-limiting toxicities (DLTs).","28 days from the last dose of IMP",{"measure":29,"description":30,"timeFrame":27},"Optimal Biological Dose (OBD)","The OBD in Module 2 (combination) will be identified based on dose-limiting toxicities (DLTs).",[32,36,38,40,42,44,46,48,52,54,56,58],{"measure":33,"description":34,"timeFrame":35},"Pharmacokinetics (PK)","PK Parameter: Maximum plasma concentration (Cmax)","From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).",{"measure":33,"description":37,"timeFrame":35},"PK parameter: Area under Curve",{"measure":33,"description":39,"timeFrame":35},"PK parameter: Time of maximum observed plasma concentration (tmax)",{"measure":33,"description":41,"timeFrame":35},"PK parameter:Terminal half-life (t½)",{"measure":33,"description":43,"timeFrame":35},"PK parameter: Plasma Clearance (CL)",{"measure":33,"description":45,"timeFrame":35},"PK parameter: Volume of Distribution (Vd)",{"measure":33,"description":47,"timeFrame":35},"PK parameter: Mean residence time (MRT)",{"measure":49,"description":50,"timeFrame":51},"To assess adverse events of special interest (AESI) by measuring infusion reaction",null,"Upto 90 days from the last dose of IMP",{"measure":53,"description":50,"timeFrame":51},"To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)",{"measure":55,"description":50,"timeFrame":51},"To assess adverse events of special interest (AESI) by measuring immune effector cell-associated neurotoxicity syndrome (ICANS)",{"measure":57,"description":50,"timeFrame":51},"To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction",{"measure":59,"description":50,"timeFrame":60},"To assess the incidence of second primary malignancies reported as adverse events of special interest (AESI) occurring during the study treatment period and long-term follow-up.","From first dose of Investigational Medicinal Product (IMP) through end of study and follow-up (up to 2 years)",{"allocation":62,"interventionModel":63,"interventionModelDescription":50,"primaryPurpose":64,"observationalModel":50,"timePerspective":50,"maskingInfo":65},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":66,"maskingDescription":50,"whoMasked":50},"NONE","This multicenter, open-label, Phase 1 trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of MT-304 in adults aged 18 and older with advanced HER2-expressing solid tumors.\n\nThe study consists of two treatment modules:\n\n* Module 1 (Monotherapy): Participants receive MT-304 every 14 days for 28-day cycles, with dosing adjustments based on clinical benefit and safety evaluations.\n* Module 2 (Combination Therapy): Participants receive MT-304 in combination with nivolumab, administered every 14 days and 28 days, respectively, also allowing for dosing adjustments.\n\nThe Bayesian Optimal Interval (BOIN) design will guide dose escalation, overseen by a Safety Review Committee to establish the recommended Phase 2 dose (RP2D).\n\nRegular assessments, including vital signs and laboratory tests, will monitor safety and efficacy throughout the trial, with follow-up visits for up to 2 years post-treatment.",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"MT-304 Monotherapy","EXPERIMENTAL","Participants receive MT-304 administered intravenously once every 14 days (Q14D) in escalating dose levels.",[74],"Drug: MT-304",{"label":76,"type":71,"description":77,"interventionNames":78},"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).",[79],"Drug: MT-304 + Nivolumab",[81,88],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"DRUG","MT-304","Safety, tolerability, and pharmacokinetics will be evaluated.",[70],[87],"mRNA-LNP",{"type":82,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"MT-304 + Nivolumab","Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.",[76],[87],[94],{"name":95,"affiliation":5,"role":96},"Matthew Maurer, MD","STUDY_DIRECTOR",[98,103],{"name":99,"role":100,"phone":101,"phoneExt":50,"email":102},"Project Manager","CONTACT","+61731376255","MTX-HER2-304_ClinicalStudy@novotech-cro.com",{"name":104,"role":100,"phone":105,"phoneExt":50,"email":106},"Clinical Department","+16174651022","mt-304.clinical@createmedicines.com",[108,128,142,157,172,187,202],{"facility":109,"status":110,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"The Kinghorn Cancer Centre","RECRUITING","Darlinghurst","New South Wales","2010","Australia","AU",{"type":117,"coordinates":118},"Point",[119,120],151.21925,-33.87939,{"lat":120,"lon":119},[123,126],{"name":124,"role":100,"phone":125,"phoneExt":50,"email":50},"Dr Rasha Cosman","+61393555655",{"name":124,"role":127,"phone":50,"phoneExt":50,"email":50},"PRINCIPAL_INVESTIGATOR",{"facility":129,"status":110,"city":130,"state":112,"zip":131,"country":114,"countryCode":115,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Scientia Clinical Research Ltd","Randwick","2031",{"type":117,"coordinates":133},[134,135],151.24895,-33.91439,{"lat":135,"lon":134},[138,141],{"name":139,"role":100,"phone":50,"phoneExt":50,"email":140},"Dr Charlotte Lemech","contactus@scientiaclinicalresearch.org.au",{"name":139,"role":127,"phone":50,"phoneExt":50,"email":50},{"facility":143,"status":110,"city":144,"state":112,"zip":145,"country":114,"countryCode":115,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Calvary Mater Newcastle","Waratah","2298",{"type":117,"coordinates":147},[148,149],151.72647,-32.90667,{"lat":149,"lon":148},[152,155],{"name":153,"role":100,"phone":154,"phoneExt":50,"email":50},"Kerrie Cornall","+61240143282",{"name":156,"role":127,"phone":50,"phoneExt":50,"email":50},"Dr Jordan Cohen",{"facility":158,"status":110,"city":159,"state":160,"zip":161,"country":114,"countryCode":115,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Icon Cancer Centre South Brisbane","South Brisbane","Queensland","4101",{"type":117,"coordinates":163},[164,165],153.02049,-27.48034,{"lat":165,"lon":164},[168,171],{"name":169,"role":100,"phone":170,"phoneExt":50,"email":50},"A\u002FProf Jermaine Coward","+61737374500",{"name":169,"role":127,"phone":50,"phoneExt":50,"email":50},{"facility":173,"status":110,"city":174,"state":175,"zip":176,"country":114,"countryCode":115,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Cancer Research SA Pty Ltd","Adelaide","South Australia","5000",{"type":117,"coordinates":178},[179,180],138.59863,-34.92866,{"lat":180,"lon":179},[183,186],{"name":184,"role":100,"phone":185,"phoneExt":50,"email":50},"Dr Meena Okera","+61883592565",{"name":184,"role":127,"phone":50,"phoneExt":50,"email":50},{"facility":188,"status":110,"city":189,"state":190,"zip":191,"country":114,"countryCode":115,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Cabrini Health","Melbourne","Victoria","3144",{"type":117,"coordinates":193},[194,195],144.96332,-37.814,{"lat":195,"lon":194},[198,201],{"name":199,"role":100,"phone":200,"phoneExt":50,"email":50},"Dr. Prachi Bhave","+61395083437",{"name":199,"role":127,"phone":50,"phoneExt":50,"email":50},{"facility":203,"status":110,"city":204,"state":205,"zip":206,"country":114,"countryCode":115,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Linear Clinical Research","Nedlands","Western Australia","6009",{"type":117,"coordinates":208},[209,210],115.8073,-31.98184,{"lat":210,"lon":209},[213,216],{"name":214,"role":100,"phone":215,"phoneExt":50,"email":50},"Dr Timothy Humphries","+61863825100",{"name":214,"role":127,"phone":50,"phoneExt":50,"email":50},{"type":218,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[220],{"name":221,"class":222},"CREATE Medicines","UNKNOWN","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":232,"type":233},60,"ESTIMATED","INTERVENTIONAL",[236],"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.",[239],"HER2-Expressing Solid Tumors",[241,242,243,244,245,246,247,248,249,250,251,252,253],"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":256,"type":257},"2026-05-20","ACTUAL",{"date":259,"type":257},"2025-11-25",{"date":261,"type":233},"2028-03-30",{"name":5,"class":6},7]