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Phase 1 Lutetium Lu 177 Edotreotide for SSTR-positive Tumors in Children

This study is testing a treatment called Lutetium Lu 177 Edotreotide in children and teenagers (ages 2 to 18) who have certain types of cancer that have come back or haven't responded to other treatments. These cancers must be "somatostatin receptor-positive" (SSTR-positive), which means the cancer cells have a specific protein on their surface. The main goals are to find the right dose of Lutetium Lu 177 Edotreotide for children, understand how it moves through the body (pharmacokinetics), and check for side effects. The study plans to enroll 20 participants. Success will be measured by finding a safe and effective dose for children.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 participants.
What's involved
You would receive Lutetium Lu 177 Edotreotide intravenously once every 8 weeks for up to 6 doses, over an average of 48 weeks. Dosimetry assessments will be done at multiple times during cycles 1, 2, and 4.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for dosage is measured at least eight weeks after the first administration of Lutetium Lu 177 Edotreotide.

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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

Recruiting
PHASE1Ages 24–18InterventionalTreatment
ITM Solucin GmbH
~20 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Lutetium Lu 177-EdotreotideAmino Acid Solution

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pediatric Dosage
Measured over a. Dosimetry assessments will be performed at multiple timepoints in cycle 1, 2 and 4. - b. Minimum of eight weeks after the first administration of Lutetium Lu 177 edotreotide

Conditions

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

Explore related trials

Central Nervous System NeoplasmGastrointestinal Stromal TumorLymphomaNeuroendocrine NeoplasmPeripheral Primitive Neuroectodermal TumorRhabdomyosarcomaSolid NeoplasmSomatostatin Receptor

Where it's being run

6 sites across 5 states
Spain2
California1
Pennsylvania1
Texas1
France1

Study leadership

  • Roman Henkel, PhD · STUDY_DIRECTOR · Director, Global Clinical Operations

Who to contact

Shahanaz Rahman
[email protected]
+4989 32989866000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants aged ≥ 2 years and \< 18 years
Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease.
Tumor which is relapsed or is refractory to at least one line of previous therapy
Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample
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)/ computed tomography (CT) or positron emission tomography (PET)/CT imaging, which is higher than the liver uptake)
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
In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT

Exclusion

Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA/Edotreotide, or excipients
Previous history of acute leukemia unless in remission for at least two years
Extensive bone/bone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells/kg
Patients who have received previous systemic targeted RPT
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.
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.
Previous treatment with oncologic immune vaccine or CAR-T cell therapy
Bulky disease in the CNS
Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction
Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment
Pregnant or breastfeeding women.
Other known malignancies.
Serious non-malignant disease.

What this trial measures

  • Pediatric Dosagea. Dosimetry assessments will be performed at multiple timepoints in cycle 1, 2 and 4. - b. Minimum of eight weeks after the first administration of Lutetium Lu 177 edotreotide

    Pediatric dosage based on: 1. absorbed dose by target organs (kidney and bone marrow). 2. rate of Dose limitting toxicities - based on adverse event reporting.