[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-tumor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100367735","alpha-radiation-emitters-device-dart-for-the-treatment-of-of-malignant-cutaneous-tumors-100367735",false,"NCT04068155","Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors","A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors","Inclusion Criteria:\n\n* Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:\n\n  * SCC\n  * BCC\n  * Lentigo maligna melanoma (Dubreuilh melanoma)\n  * Carcinosarcoma\n* Acceptable tumor locations include the following:\n\n  * Skin (facial, scalp, extremities, torso)\n  * Lips\n  * Eyelids\n* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.\n* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.\n* Measurable disease according to RECIST v1.1.\n* Subjects over 18 years old.\n* Subjects' ECOG Performance Status Scale is \\\u003C 2.\n* Subjects' life expectancy is more than 6 months.\n* Platelet count ≥100,000\u002Fmm3.\n* International normalized ratio of prothrombin time ≤1.8.\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.\n* Subjects are willing to sign an informed consent form\n\nExclusion Criteria:\n\n* Subject has a tumor with histology of one of the following:\n\n  * Keratoacanthoma\n  * Merkel cell carcinoma\n  * Sarcoma other than carcinosarcoma\n* Metastatic disease (according to the TNM staging system - M1 patients are excluded)\n* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Subjects not willing to sign an informed consent.\n* Women who are pregnant or breastfeeding.","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"NA","A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors",[26,27,28],"Skin Cancer","Cutaneous Tumor","Cutaneous Metastasis",[30,31,26,32,33,34,35,36,37,38,39,40,41,42,43],"Squamous Cell Carcinoma","Basal Cell Carcinoma","Skin Metastasis","Superficial Sarcoma","Alpha Radiation","Cutaneous Lesion","Brachytherapy","Radiotherapy","Lentigo maligna melanoma","Carcinosarcom","scalp cancer","Lip cancer","Eyelid cancer","SCC","RECRUITING","2026-06-15",{"date":47,"type":48},"2026-06-16","ACTUAL",{"date":50,"type":48},"2022-04-01",{"date":52,"type":20},"2028-01",{"name":54,"class":55},"Alpha Tau Medical LTD.","INDUSTRY",{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":78,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100529282","phase-1-phase-i-study-of-tolododekin-alfa-ank-101-in-advanced-solid-tumors-100529282","NCT06171750","Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors","A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors","ANCHOR","Inclusion Criteria:\n\n* ≥ 18 years of age on day of signing informed consent\n* histologically or cytologically confirmed diagnosis of cutaneous, subcutaneous, soft tissue, or nodal advanced solid tumor malignancy; metastatic disease eligible\n* measurable disease per RECIST v1.1 - Note: Must have at least 1 tumor lesion with longest dimension of ≥ 10 mm (≥ 15 mm for the short axis for malignant lymph node lesions) that - For Part 1 only: can be easily palpated or detected by ultrasound to facilitate IT injection of ANK-101 (i.e., tumor in skin, muscle, subcutaneous tissue, or accessible lymph node) or; - For Part 2 only: can be accessed by interventional radiologic or endoscopic procedures for injection (e.g., ultrasound or computed tomography \\[CT\\] guided). - For Part 2 Dose Expansion Cohort only: Histologically confirmed Stage III or Stage IV NSCLC\n* Part 3 CSCC Combination Cohort: Histologically confirmed high-risk locally advanced or metastatic CSCC not amenable to surgical management as determined by a multidisciplinary tumor board.\n* documented disease progression, be refractory to, or intolerant of existing SOC therapy(ies) known to provide clinical benefit (including surgical cure) or not be eligible for SOC therapy(ies)\n* ECOG performance status 0-1\n* life expectancy \\> 12 weeks\n* adequate bone marrow, hepatic and renal function\n* baseline electrocardiogram (EKG) without evidence of acute ischemia or prolonged QTc interval \\> 460 msec\n* Human immunodeficiency virus (HIV) infected participants must be on anti-retroviral therapy (ART) and have well-controlled HIV infection\u002Fdisease\n* last dose of previous anticancer therapy (including investigational agents) ≥ 28 days, radiotherapy ≥ 14 days (targeted palliative radiotherapy is allowed for lesions not planned for injections), or surgical intervention ≥ 21 days prior to the start of treatment\n* resolution of all prior anticancer therapy toxicities (except for alopecia or vitiligo) to ≤ Grade 1 (as per NCI CTCAE Version 5.0)\n* willing to provide pre- and post-treatment tumor biopsy samples if medically feasible\n* participant is capable of understanding and complying with protocol requirements\n\nExclusion Criteria:\n\n* injectable tumors impinging upon major airways or blood vessels\n* prior treatment with recombinant interleukin-12 (IL-12)\n* have received systemic therapy with immunosuppressive agents ≤ 28 days before the start of treatment\n* have received live vaccines within 28 days prior to the start of ANK-101 treatment\n* have primary or acquired immunodeficient states (e.g., leukemia, lymphoma)\n* a woman of childbearing potential (WOCBP) who has a positive serum pregnancy test (within 72 hours) prior to the start of treatment or female participant who is breastfeeding\n* prior organ transplantation\n* known history of hepatitis B virus, known active hepatitis C virus, or a positive serological test at screening within 28 days prior to the start of treatment\n* HIV-infected participants with a history of Kaposi sarcoma and\u002For Multicentric Castleman Disease\n* active autoimmune disease or medical conditions requiring chronic steroid (i.e., ≥ 20 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 28 days prior to the start of treatment\n* known active central nervous system (CNS) metastases\n* congestive heart failure (\\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest), or clinically significant cardiac arrhythmias\n* uncontrolled bleeding disorders within 4 weeks prior to the start of treatment or known bleeding diathesis - Note: Part 2 only: Participants with active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures\n* history of hypersensitivity to compounds of similar biological composition to IL-12, aluminum hydroxide, or drugs formulated with polysorbate-20\n* other systemic conditions or organ abnormalities that, in the opinion of the Investigator, may interfere with the conduct and\u002For interpretation of the current study\n* any acute or chronic psychiatric problems or substance abuse disorder that, in the opinion of the Investigator, make the participant unsuitable for participation\n* Part 3 only: prior Grade 3 or greater immune-mediated adverse events (imAEs) following treatment with an agent that blocks the programmed cell death protein 1 (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) pathway.\n* Part 3 only: hypersensitivity to cemiplimab or any of its excipients or contraindications to cemiplimab per approved local labeling",{"count":65,"type":20},97,[67],"PHASE1","This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of tolododekin alfa (ANK-101) in participants with advanced solid tumors who have progressed during or after receiving standard of care (SOC) therapy or who will not benefit from such therapy. The study will be conducted in three parts; in Part 1, participants with superficial lesions will receive ANK-101 as a single agent; in Part 2, participants with visceral lesions will receive ANK-101 as a single agent; and in Part 3, participants with cutaneous squamous cell carcinoma (CSCC) will receive ANK-101 in combination with cemiplimab.",[70,27,71,72,73,74,75,76,77],"Advanced Solid Tumor","Subcutaneous Tumor","Malignant Solid Tumor","Solid Tumor","Metastatic Solid Tumor","Metastasis to Soft Tissue","Non Small Cell Lung Cancer","Cutaneous Squamous Cell Carcinoma",[79,80,81,82,83,84,85],"intratumoral","intratumoral injection","solid tumors","superficial tumors","nodal tumors","subcutaneous tumors","visceral tumors","2026-03-04",{"date":88,"type":48},"2026-03-06",{"date":90,"type":48},"2024-01-19",{"date":92,"type":20},"2027-06",{"name":94,"class":55},"Ankyra Therapeutics, Inc",5]