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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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).

NCT06441331•ITM Solucin GmbH

View on ClinicalTrials.gov

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.

Detailed Description

Determine the dose, pharmacokinetics and safety of Lutetium Lu 177 Edotreotide as monotherapy or following sequential standard of care in pediatric participants with recurrent, progressive or refractory NET, CNS, lymphoma and other solid tumors that express SSTRs by immunohistochemistry and demonstrate uptake by somatostatin receptor imaging. Lutetium Lu 177 Edotreotide will be given intravenously once every 8 weeks for a total of up to 6 doses over an average of 48 weeks in participants aged 2-18 years.

Eligibility

Age

2 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•Screening Consent Participant/legal 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.

Exclusion Criteria

•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
+3 more criteria

Locations (2)

The Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States

Hospital Universitario Vall d'Hebron - Oncología Médica

Barcelona, Spain

Key Dates

Start Date

September 26, 2025

Primary Completion Date

June 1, 2028

Completion Date

April 1, 2034

Last Updated

December 17, 2025

Enrollment

ESTIMATED participants

Conditions

Somatostatin Receptor PositiveNETsLymphomaSolid TumorCNS TumorsRhabdomyosarcomaPeripheral Primitive Neuroectodermal TumorGIST

Interventions

Lutetium Lu 177-Edotreotide

DRUG

Amino Acid Solution

OTHER

Contacts

Shahanaz Rahman

CONTACT

+4989 32989866000 kinlet@itm-radiopharma.com

Serhii Melnyk, MD

CONTACT

kinlet@itm-radiopharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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