[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654557":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":41,"studyPopulation":34,"armGroups":42,"interventions":49,"overallOfficials":34,"centralContacts":56,"locations":64,"responsibleParty":89,"collaborators":34,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":34,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":34,"enrollmentInfo":100,"targetDuration":34,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":112,"overallStatus":67,"whyStopped":34,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":34},[9,13],{"measure":10,"description":11,"timeFrame":12},"Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions","Standardized uptake values (SUVs) will be measured in organs of interest, normal tissues, and tumor lesions based on positron emission tomography (PET) imaging.","Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155",{"measure":14,"description":15,"timeFrame":12},"Standardized uptake value ratio (SUVr) of [68Ga]Ga-DWJ155 in tumor lesions relative to reference organs","Standardized uptake value ratios (SUVr) will be calculated as the ratio of SUV in tumor lesions to SUV in normal organs.",[17,21,25,28,31],{"measure":18,"description":19,"timeFrame":20},"Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)","Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.","Up to 3 days after the administration of [68Ga]Ga-DWJ155",{"measure":22,"description":23,"timeFrame":24},"Area under the concentration-time curve (AUC) of blood radioactivity (Imaging characterization part only)","Pharmacokinetic (PK) analysis will be performed in the imaging characterization part based on decay-corrected blood radioactivity concentration data. These data will be converted to mass units for PK analysis, and AUC will be determined using non-compartmental methods.","From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155",{"measure":26,"description":27,"timeFrame":24},"Maximum observed concentration (Cmax) of blood radioactivity (Imaging characterization part only)","PK analysis will be performed in the imaging characterization part based on decay-corrected blood radioactivity concentration data. These data will be converted to mass units for PK analysis, and Cmax will be determined using non-compartmental methods.",{"measure":29,"description":30,"timeFrame":12},"Absorbed radiation dose in selected organs and total body (Imaging characterization part only)","Absorbed radiation dose will be estimated for organs of interest and whole body based on serial positron emission tomography (PET) imaging.",{"measure":32,"description":33,"timeFrame":12},"Effective radiation dose (Imaging characterization part only)","Effective radiation dose will be calculated based on the estimated absorbed radiation doses in source organs, with adjustments for individual body weight and organ masses (derived from computed tomography imaging).",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":40,"maskingDescription":34,"whoMasked":34},"NONE","This is an open-label, Phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, pharmacokinetics (PK), and dosimetry properties of \\[68Ga\\]Ga-DWJ155.\n\nHER2 status for enrollment will be determined based on the most recent, locally available tumor tissue sample and corresponding HER2 results, in accordance with the American Society of Clinical Oncology (ASCO) \u002F College of American Pathologists (CAP) guidelines, as applicable.\n\nThis study comprises an imaging characterization part and an expansion part. During the imaging characterization part, the imaging characteristics of \\[68Ga\\]Ga-DWJ155 (e.g., biodistribution, tumor uptake, and radiation dosimetry) will be assessed, as well as the optimal imaging time point for tumor visualization. The expansion part may be initiated if positive tumor uptake is observed in patients during the imaging characterization part.\n\nThe estimated study duration for each individual patient is up to approximately 32 days, including a screening period of up to 28 days, a single-day imaging period (including \\[68Ga\\]Ga-DWJ155 administration and assessments), and a 3-day safety follow-up.",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"[68Ga]Ga-DWJ155","EXPERIMENTAL","Single administration of \\[68Ga\\]Ga-DWJ155",[48],"Diagnostic Test: [68Ga]Ga-DWJ155",[50],{"type":51,"name":44,"description":52,"armGroupLabels":53,"otherNames":54},"DIAGNOSTIC_TEST","Radioligand imaging agent",[44],[55],"FKL480",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":34,"email":61},"Novartis Pharmaceuticals","CONTACT","+41613241111","novartis.email@novartis.com",{"name":58,"role":59,"phone":63,"phoneExt":34,"email":34},"+81337978748",[65,79],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":34},"Novartis Investigative Site","RECRUITING","Darlinghurst","New South Wales","2010","Australia","AU",{"type":74,"coordinates":75},"Point",[76,77],151.21925,-33.87939,{"lat":77,"lon":76},{"facility":66,"status":67,"city":80,"state":34,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":34},"Kyoto","6068507","Japan","JP",{"type":74,"coordinates":85},[86,87],135.75385,35.02107,{"lat":87,"lon":86},{"type":90,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100654557","phase-1-a-study-of-68gaga-dwj155-in-adult-patients-with-solid-tumors-100654557",false,"NCT07801508","A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors","A Phase I, Open Label Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patients with one of the following indications:\n\n  * HR+\u002FHER2- aBC and TNBC: untreated or currently receiving or having completed first line of systemic therapy (preferred); HER2+ aBC: regardless of any prior systemic therapy\n  * aNSCLC adenocarcinoma: Prior to, during or having completed their first line of systemic therapy. If HER2 immunohistochemistry (IHC) will be routinely performed and available, then HER2 ≥1+\n  * aGEA: regardless of any prior systemic line of therapy\n\nKey Exclusion Criteria:\n\n* Out-of-range laboratory values defined as:\n\n  * Estimated glomerular filtration rate (eGFR; calculated using CKD-EPI 2021 formula, or measured) \\\u003C 40 mL\u002Fmin\u002F1.73m2\n  * Platelet count \\\u003C 75 x 10\\^9\u002FL\n  * Hemoglobin \\\u003C 9 g\u002FdL\n  * Absolute neutrophil count (ANC) \\\u003C 1.0 x 10\\^9\u002FL\n* Patients with inadequate hepatic function\n* Urinary tract obstruction or urinary incontinence\n* Pregnant or breastfeeding women\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":101,"type":102},66,"ESTIMATED","INTERVENTIONAL",[105],"PHASE1","The purpose of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics (PK) of \\[68Ga\\]Ga-DWJ155, also known as FKL480, in patients ≥ 18 years of age with advanced gastroesophageal adenocarcinoma (aGEA, where GEA is defined as adenocarcinomas of the distal esophagus, the gastroesophageal junction, and the stomach), hormone receptor (HR) positive\u002Fhuman epidermal growth factor receptor 2 (HER2) negative (HR+\u002FHER2-) advanced breast cancer (aBC), HER2 positive (HER2+) aBC, triple-negative breast cancer (TNBC) and advanced non-small cell lung cancer (aNSCLC) adenocarcinoma.",[108,109,110,111],"Advanced Gastroesophageal Adenocarcinoma","Advanced Breast Cancer","Triple-negative Breast Cancer","Advanced Non-small Cell Lung Cancer",[113,114,115,116,117,44,55,118,119,120,121,122,123],"Gastroesophageal adenocarcinoma (GEA)","Gastric cancer (GC)","Breast cancer (BC)","Non-small cell lung cancer (NSCLC)","Radioligand imaging (RLI)","Gallium","Adenocarcinoma","Positron emission tomography (PET)","Dosimetry","HER2","Radiopharmaceutical","2026-10-09",{"date":126,"type":127},"2026-10-13","ACTUAL",{"date":129,"type":127},"2026-09-08",{"date":131,"type":102},"2028-06-30",{"name":58,"class":6},2]