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
Single group
Lutetium Lu 177-Edotreotide
Druglutetium Lu 177 edotreotide At least two cycles and a maximum of six cycles at eight-week (± 2 we-ek) intervals. Extrapolation from standard maximum adult dose of 100 Megabecquerel(MBq)/kg for a 75 kg adult for the first cohort. Dosing decision for the subsequent cohorts by Data Monitoring Committee (DMC), based on (at least) cycle 1 dosimetry and safety data from at least four participants of the preceding cohort. Route of administration: Intravenous (IV) infusion. Duration of treatment: 16-48 weeks
Amino Acid Solution
Other interventionThe Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
Pediatric Dosage
Pediatric dosage based on: 1. absorbed dose by target organs (kidney and bone marrow). 2. rate of Dose limitting toxicities - based on adverse event reporting.
Objective Response Rate
Assess preliminary anti-tumor activity by tumor type
PK and dosimetry
Lutetium Lu 177 edotreotide PK evaluation and tumor and target organ dosimetry
Rate of adverse events
Safety evaluation of Lutetium Lu 177 edotreotide targeted RPT as monotherapy or following standard of care
Overall Survival, Progression-Free Survival and Duration of Response
Additional preliminary efficacy evaluation of lutetium Lu 177 Edotreotide targeted RPT as monotherapy or following SoC
Exploratory Endpoint: Quality of Life
Assess quality of life based on the adapted Quality of Life (QoL) scale (PedsQL TM 3.0 Cancer Module)
Exploratory Endpoint: Correlation between SSTR expression detected by immunohisto-chemistry and functional imaging
Correlation of the expression level of SSTR immunohistochemistry in tumor biopsy or surgery samples and 111In-based, 99mTc-based, or 68Ga-based-based lesion uptake (regarding intensity/distribution)
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