[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2--breast-cancer-her2--gastric-cancer-squamous-cell-carcinoma-of-head-and-neck-esophageal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2--breast-cancer-her2--gastric-cancer-squamous-cell-carcinoma-of-head-and-neck-esophageal-squamous-cell-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100579768","early-phase-1-pilot-study-of-68gaga-aby-025-imaging-in-patients-undergoing-treatment-with-her2-targeted-therapy-100579768",false,"NCT06828588","Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the discretion of their treating physician for an FDA-approved indication. Patients who are planning to start HER2-targeted therapy at the time of study enrollment. Patients who have recently begun HER2 treatment and have received no more than 6 cycles will be eligible for enrollment.\n3. Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type.\n4. Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.\n5. Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study.\n\nExclusion Criteria:\n\n1. Measurable sites of disease only in the liver.\n2. Inability to comply with study procedures.\n3. Hypersensitivity or allergy to any component of \\[68Ga\\]Ga-ABY-025.\n4. Pregnant or breastfeeding.\n5. HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.\n6. Inability to lie flat for 30 minutes during an imaging session.\n7. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","The purpose of this study is to determine if the radiotracer, \\[68Ga\\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.",[25,26,27,28,29],"Locally Advanced Cancer","Metastatic Cancer","HER2","HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma","HER 2 Low-expressing Breast Cancer",[27,31,32,33,34,35,36,37,38,39,40,41,42,43],"cancer","advanced cancer","metastatic","IHC","FISH","trastuzumab","T-DM1","Pertuzumab","Margetuximab","Neratinib","Lapatinib","Tucatinib","Everolimus","RECRUITING","2026-05-06",{"date":47,"type":48},"2026-05-08","ACTUAL",{"date":50,"type":48},"2026-04-16",{"date":52,"type":19},"2029-12",{"name":54,"class":55},"Vanderbilt-Ingram Cancer Center","OTHER"]