CLINICAL_TRIALS ClinicalTrials.gov record update

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).

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT06441331
Title field or adapter rule: {'original_value': '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).', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:31.111488+00:00
Published At: 2026-10-27T00:00:00+00:00
Record Updated At: 2026-10-27
Source Retrieved At: 2026-10-31T22:18:28.651351+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

protocolSection.conditionsModule.conditions: ["Somatostatin Receptor Positive", "NETs", "Lymphoma", "Solid Tumor", "CNS Tumors", "Rhabdomyosarcoma", "Peripheral Primitive Neuroectodermal Tumor", "GIST"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-27", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT06441331"
protocolSection.identificationModule.officialTitle: "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)."
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE1"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

{'armGroupLabels': ['Three sequential age cohorts'], 'description': 'lutetium Lu 177 edotreotide At least two cycles and a maximum of six cycles at eight-week (± 2 we-ek) intervals. Extrapolation from standard maximum adult dose of 100 Megabecquerel(MBq)/kg for a 75 kg adult for the first cohort. Dosing decision for the subsequent cohorts by Data Monitoring Committee (DMC), based on (at least) cycle 1 dosimetry and safety data from at least four participants of the preceding cohort. Route of administration: Intravenous (IV) infusion. Duration of treatment: 16-48 weeks', 'name': 'Lutetium Lu 177-Edotreotide', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Three sequential age cohorts'], 'description': 'The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.', 'name': 'Amino Acid Solution', 'type': 'OTHER'} (protocolSection.armsInterventionsModule.interventions[])

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