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.
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
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
ITM Solucin GmbH
Lead sponsor