About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Lutetium Lu 177-Edotreotide
- Amino Acid Solution