[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-solid-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-solid-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100544511","phase-2-her2-targeted-molecular-imaging-in-mbc-and-other-metastatic-solid-carcinomas-using-68ga-abs011-100544511",false,"NCT06369831","HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011","Evaluating the Diagnostic Performance of Human Epidermal Growth Factor Receptor 2 (HER2) Targeted Positron Emission Tomography and Computed Tomography (PET\u002FCT) With 68Ga-ABS011 in Metastatic Breast Cancer (mBC) and Other Metastatic Solid Carcinomas.","HERMIA","Inclusion Criteria:\n\n1. Adult (≥ 18 years at the time of informed consent signature) male or female patient\n2. Patient with confirmed de novo or pre-treated metastatic solid tumors (multiple previous treatment lines in metastatic setting are allowed).\n\n   2.1. Patients with documented hormone receptor positive\u002FHER2 negative, triple-negative or HER2 positive mBC that could become eligible for commercially available HER2 targeted monotherapy (i.e. through confirmation of HER2 IHC non-0 status assessed during the course of the study) or 2.2 Other metastatic solid tumors, not necessarily eligible for commercially available HER2 targeted monotherapy .\n3. Patient presenting with at least one target biopsiable, FDG positive , non-liver metastatic lesion of ≥15 mm defined on ceCT (as part of screening 18F-FDG PET\u002FceCT assessment).\n4. Patient willing to undergo at least one tumor biopsy.\n5. Male patients able to father children and female patients of childbearing potential agree to use effective methods of contraception during the diagnostic and SOCa treatment follow-up study phases.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to\n7. Ability and willingness of the research participant to provide written informed consent.\n\nExclusion Criteria:\n\n1. Primary (non-metastatic) solid tumor cancer.\n2. Patient not willing to undergo at least one tumor biopsy. Note: A recent biopsy and accompanied locally assessed IHC\u002FISH analyses, completed before screening, will not be accepted for study purposes.\n3. 18F-FDG PET\u002FceCT completed before screening and patient not willing to repeat this assessment.\n4. Metastatic setting 18F-FDG PET\u002FceCT indicating that the identified tumor lesions cannot be biopsied due their location and\u002For tissue type and\u002For an increased risk for serious comorbidities.\n5. Brain and liver metastases are the sole sites of metastatic disease.\n6. Life expectancy lower than 3 months.\n7. Pregnancy or breastfeeding.\n8. Inadequate organ function, suggested by clinically relevant abnormal laboratory results:\n\n   1. Significantly impaired renal function defined as estimated Glomerular Filtration Rate (GFR) \\\u003C30 ml\u002Fmin\u002F1.73m2.\n   2. Absolute neutrophil count \\\u003C1,500 cells\u002Fmm3.\n   3. Total bilirubin \\~1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome).\n   4. Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)\u002F serum glutamic pyruvic transaminase (SGPT) \\>5.0 x ULN.\n9. Patients with a known hypersensitivity to any of the investigational medicinal product (IMP) components or packaging.\n10. Patients with increased risks of bleeding or other complications from biopsies (e.g. patients under anticoagulation therapy for whom temporary discontinuation of this therapy cannot be safely performed).\n11. Patients with a known hypersensitivity or contraindication for iodinated contrast media (iCM) which cannot be controlled by taking prophylactic measures (e.g. temporary treatment interruption or introduction of adequate pre-medication).\n12. Patients who cannot undergo PET\u002FCT scanning (including but not limited to body size and claustrophobia).\n13. Any condition that in the opinion of the investigator may significantly interfere with study compliance (including but not limited to psychological or psychiatric, social or geographical condition potentially hampering compliance with the study requirements).","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET\u002FCT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization (ISH) and imaging tools used for treatment response follow-up including Fluorodeoxyglucose F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography (ceCT).",[27,28],"Metastatic Breast Cancer","Metastatic Solid Cancer",[30,31,32,33,34,35,36,37,38],"radiolabeled","single domain antibody","68Ga","Gallium-68","HER2","PET\u002FCT","metastatic cancer","metastatic solid tumor","metastatic breast cancer","RECRUITING","2026-06-01",{"date":42,"type":43},"2026-06-02","ACTUAL",{"date":45,"type":43},"2024-09-12",{"date":47,"type":21},"2026-09",{"name":49,"class":50},"Abscint NV\u002FSA","INDUSTRY",7,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100640093","phase-1-a-study-in-people-with-advanced-cancer-to-test-how-well-different-doses-of-bi-3819026-are-tolerated-when-taken-alone-and-together-with-ezabenlimab-100640093","NCT07607678","A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab","A First-in-human Phase I, Open-label, Multicentre, Dose Escalation Trial of BI 3819026 in Combination With Ezabenlimab in Patients With Unresectable Advanced or Metastatic Solid Cancers to Determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE)","Inclusion Criteria :\n\n1. Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven clinical benefit, or have declined such therapy.\n2. At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1\n3. Patients with brain metastases are eligible provided they meet the following criteria:\n\n   * Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,\n   * Radiotherapy and\u002For surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,\n   * Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment.\n4. Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement between the investigator and the Sponsor\n5. All toxicities related to previous anti-cancer therapies have resolved to Grade ≤1 or baseline prior to trial treatment administration (except for alopecia, peripheral neuropathy and endocrinopathies considered irreversible \\[like hypothyroidism\\], and amenorrhea\u002Fmenstrual disorders which can be any grade)\n6. Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.\n\nExclusion Criteria :\n\n1. Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:\n\n   * Effectively treated non-melanoma skin cancers\n   * Effectively treated carcinoma in situ of the cervix\n   * Effectively treated ductal carcinoma in situ of the breast\n   * Other effectively treated malignancy that is considered cured by local treatment\n2. Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)\n3. Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment\n4. Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:\n\n   * Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)\n   * Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed\n5. Active\u002Fprevious history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)\n6. Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma\u002Fatopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and\u002For controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible\n7. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)\n8. Patients with history of HIV infection who meet one or more of the following criteria:\n\n   * CD4+ count \\\u003C350 cells\u002FµL\n   * Viral load \\>400 copies\u002FmL\n   * Not receiving antiretroviral therapy\n   * Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment\n   * History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the exclusion criteria above are eligible to participate but the patient must be under the care of an HIV\u002FInfectious Diseases specialist, or an HIV\u002FInfectious Diseases specialist must be consulted prior to inclusion Further exclusion criteria apply.",{"count":20,"type":21},[61],"PHASE1","This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer.\n\nParticipants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study.\n\nParticipants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.",[64,28],"Advanced Solid Cancer","2026-05-27",{"date":67,"type":43},"2026-05-29",{"date":69,"type":43},"2026-05-01",{"date":71,"type":21},"2030-10-15",{"name":73,"class":50},"Boehringer Ingelheim",9]