[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-primitive-neuroectodermal-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-primitive-neuroectodermal-tumor":34},{"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":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100549997","phase-1-phase-i-trial-to-determine-the-dose-and-evaluate-the-pk-and-safety-of-lutetium-lu-177-edotreotide-therapy-in-pediatric-participants-with-sstr-positive-tumors-100549997",false,"NCT06441331","Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors","A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).","KinLET","Key Inclusion Criteria:\n\n* Participants aged ≥ 2 years and \\\u003C 18 years\n* Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease.\n* Tumor which is relapsed or is refractory to at least one line of previous therapy\n* Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample\n* Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)\u002F computed tomography (CT) or positron emission tomography (PET)\u002FCT imaging, which is higher than the liver uptake)\n* Participants must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria, excluding alopecia, stable treated electrolyte abnormalities on replacement and stable treated hypothyroidism) of all prior treatment modality prior to entering this trial\n* In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT\n\nScreening Consent Participant\u002Flegal guardian is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA\u002FEdotreotide, or excipients\n* Previous history of acute leukemia unless in remission for at least two years\n* Extensive bone\u002Fbone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells\u002Fkg\n* Patients who have received previous systemic targeted RPT\n* Previous treatment with metaiodobenzyl guanidine (MIBG) if the predicted overall exposure is expected to exceed 2 Gy (gray) to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with external beam radiation therapy (EBRT) if the predicted overall exposure is expected to exceed more than 2 Gy to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with oncologic immune vaccine or CAR-T cell therapy\n* Bulky disease in the CNS\n* Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction\n* Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment\n* Pregnant or breastfeeding women.\n* Other known malignancies.\n* Serious non-malignant disease.","ALL","24 Months","18 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \\\u003C18 years of age with somatostatin receptor (SSTR)-positive tumors.",[28,29,30,31,32,33,34,35],"Somatostatin Receptor Positive","NETs","Lymphoma","Solid Tumor","CNS Tumors","Rhabdomyosarcoma","Peripheral Primitive Neuroectodermal Tumor","GIST",[37,38,39,30,40,41,42,43,44,45,46,47],"Pediatric","CNS tumors","Solid tumors","Somatostatin Receptor (SSTR)-positive Tumors","Lutetium Lu 177 Edotreotide","Targeted RPT","ITM","GEP-NET","Neuroendocrine tumors","Radiopharmaceutical Therapy","Childhood","RECRUITING","2026-04-27",{"date":51,"type":52},"2026-05-01","ACTUAL",{"date":54,"type":52},"2025-09-26",{"date":56,"type":22},"2034-04",{"name":58,"class":59},"ITM Solucin GmbH","INDUSTRY",5]