Tests lutetium-177 edotreotide in children with somatostatin receptor-positive tumors

Trial details

Who runs it

ITM Solucin GmbH

Trial code

NCT06441331EU 2024-512831-66-00

Record updated

27 October 2026

Original description

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.Read full original descriptionShow less

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).

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.

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; 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: Previous history of acute leukemia unless in remission for at least two years; 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; Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment; Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA/Edotreotide, or excipients; Bulky disease in the CNS; Other known malignancies; Serious non-malignant disease; 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; Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction; Pregnant or breastfeeding women.

ClinicalTrials.gov NCT06441331 · EU CTIS 2024-512831-66-00