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 (KinLET)
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
A observational or N/A phase clinical study on CNS Tumors and GIST, this trial is actively recruiting participants. The trial is conducted by ITM Solucin GmbH and has accumulated 7 data snapshots since 2025. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE1 → None
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Jan 2026 — May 2026 [monthly]
Recruiting PHASE1
Status: Not Yet Recruiting → Recruiting
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Oct 2025 — Jan 2026 [monthly]
Not Yet Recruiting PHASE1
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Dec 2024 — Oct 2025 [monthly]
Not Yet Recruiting PHASE1
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Oct 2024 — Dec 2024 [monthly]
Not Yet Recruiting PHASE1
▶ Show 2 earlier versions
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Sep 2024 — Oct 2024 [monthly]
Not Yet Recruiting PHASE1
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Jul 2024 — Sep 2024 [monthly]
Not Yet Recruiting PHASE1
First recorded
Eligibility 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.
Contact Information
- ITM Solucin GmbH
For direct contact, visit the study record on ClinicalTrials.gov .