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
Start Date
9/26/2025
Completion Date
4/1/2034
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.
Detailed Description
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.
Eligibility Criteria
Age Range: No minimum to 18 years
Interventions
Lutetium Lu 177-Edotreotide
Amino Acid Solution
Conditions
Locations
UCSF Benioff Children's Hospital
San Francisco, California 94158
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania 19104-4319
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas 77030
United States
Gustave Roussy Cancer Campus
Villejuif, 94800
France
Hospital Universitario Vall d'Hebron - Oncología Médica
Barcelona, 08035
Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Spain