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

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.

NCT Number	NCT06441331
Lead Sponsor	ITM Solucin GmbH
Conditions	Somatostatin Receptor Positive, NETs, Lymphoma, Solid Tumor, CNS Tumors, Rhabdomyosarcoma, Peripheral Primitive Neuroectodermal Tumor, GIST
Enrollment	20 participants
Start Date	2025-09-26
Primary Completion	2028-06 (estimated)
Study Completion	2034-04 (estimated)
Updated on ClinicalTrials.gov	2026-08-04