RecruitingPhase 1NCT06441331

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).


Sponsor

ITM Solucin GmbH

Enrollment

20 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 \<18 years of age with somatostatin receptor (SSTR)-positive tumors.


Eligibility

Min Age: 24 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a radioactive drug called Lutetium-177 edotreotide — which delivers targeted radiation directly to tumor cells — in children with rare cancers called SSTR-positive tumors (tumors that have a specific protein receptor on their surface), including certain brain tumors and neuroendocrine tumors. **You may be eligible if...** - You are between 2 and 17 years old - You have a confirmed diagnosis of an SSTR-positive tumor (cancer with specific surface receptors) - Your cancer has come back or stopped responding to at least one previous treatment - You are otherwise well enough to participate **You may NOT be eligible if...** - You have significant kidney, liver, or bone marrow problems - You have had recent radiation therapy to the same areas - You are pregnant (or could be pregnant) - Your cancer does not test positive for SSTR receptors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLutetium Lu 177-Edotreotide

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

OTHERAmino Acid Solution

The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.


Locations(5)

The Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Gustave Roussy Cancer Campus

Villejuif, France

Hospital Universitario Vall d'Hebron - Oncología Médica

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

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NCT06441331


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