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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

Testing safe dose of Lu 177 Edotreotide in kids with tumors.

Recruiting
24-18 years
All
Phase 1

This study is for kids aged 2 to under 18 years who have specific types of tumors that show a protein called somatostatin receptor (SSTR). The study will check how safe and effective a medicine called Lutetium Lu 177 Edotreotide is. This medicine is a type of Targeted Radiopharmaceutical Therapy (RPT), which means it uses special radioactive materials to target and treat cancer cells. The medicine will be given through an IV every 8 weeks, up to 6 times over about 48 weeks.

  • The study requires regular visits every 8 weeks for up to 6 doses.
  • Participants must have a specific type of tumor that shows SSTR and has not responded to previous treatments.
  • Certain health conditions and past treatments could disqualify participants.

Children who join should have a confirmed SSTR-positive tumor and must not have certain health issues, like severe kidney or liver problems. Parents or guardians need to sign a consent form before participation, and if suitable, kids will also give their agreement, called assent.

Study details
    Somatostatin Receptor Positive
    NETs
    Lymphoma
    Solid Tumor
    CNS Tumors
    Rhabdomyosarcoma
    Peripheral Primitive Neuroectodermal Tumor
    GIST

NCT06441331

ITM Solucin GmbH

8 August 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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