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

Inclusion Criteria

• •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
• •Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)/ computed tomography (CT) or positron emission tomography (PET)/CT imaging, which is higher than the liver uptake)
• •Participants must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria, excluding alopecia, stable treated electrolyte abnormalities on replacement and stable treated hypothyroidism) of all prior treatment modality prior to entering this trial
• •In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT
• •Screening Consent Participant/legal guardian is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.