Phase I Study to Find the Right Dose and Check Safety of Lutetium Lu 177 Edotreotide Therapy for Children Ages 2 to Under 18 with Somatostatin Receptor-Positive Tumors

What this Trial Is About

Researchers are evaluating Lutetium Lu 177 Edotreotide targeted radiopharmaceutical therapy in children aged 2 to under 18 years who have somatostatin receptor-positive tumors, including neuroendocrine tumors, CNS tumors, lymphoma, and other solid tumors. The study aims to determine the correct pediatric dose, understand how the drug moves through the body, and assess its safety when given as a single treatment or after standard therapies. Participants receive the study drug intravenously every 8 weeks for up to 6 doses over about 48 weeks. The study groups are based on age cohorts 12 to under 18 years, 6 to under 12 years, and 2 to under 6 years, with dosing decisions made sequentially based on safety and dosimetry data. An amino acid solution is also used as part of the treatment. Throughout the study, participants will have dosimetry assessments at multiple timepoints during treatment cycles 1, 2, and 4, and safety will be monitored from the start of treatment until several weeks after the last dose. Researchers will also evaluate tumor response rates, overall survival, progression-free survival, and duration of response. The total participation time can last up to several years, with regular evaluations every 9 weeks until disease progression or for up to two years.

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