A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET)

Pediatric patients two years of age and above with somatostatin receptor positive (SSTR-positive) solid tumors or lymphoma, recurrent/refractory to at least one prior line of therapy

Determine the recommended dose defined as the highest lutetium Lu 177 edotreotide dose which will comply with all the following criteria: 1. The median kidney absorbed dose of lutetium Lu 177 edotreotide is below 23 Gy for full treatment. 2. The median bone marrow absorbed dose is below 2 Gy for full treatment 3. Acceptable dose limiting toxicity (DLT) profile (based on adverse event reporting) as evaluated by the data monitoring committee (DMC)

Objective Response Rate (ORR): proportion of targeted RPT-treated participants with a complete response (CR) or partial response (PR), evaluated by the Investigator, under consideration of available guidelines for monitoring response in the different tumors involved (please see protocol for further details), Rate of AEs: occurrence of AEs, severity, seriousness (including SAEs), adverse reactions of special interest, SUSARs, AEs of special interest (AESIs), outcome, treatment/trial procedure-relatedness, action taken (including any treatment, and including any change in administration of the trial drug/auxiliary medication),dose-modifying toxicity (DMT), DLT. Pre and post administration: vital signs, physical examination, ECG, safety laboratory parameters (please see protocol for further details), Overall Survival (OS) PFS and Duration of Response (DoR) According to Investigator’s criteria, based on anatomical/functional imaging (MRI and/or CT and/or PET/CT and/or SPECT/CT): every nine ± 3 weeks (depending on histology or tumor type) from enrollment until adequately documented disease progression or for up to two years according to the current guidelines appropriate for the applicable tumor types, The following assessments, done in cycles 1 and 2;in addition, and a reduced number of measurements of the below mentioned assessments per method done in cycle 4, the timepoints of these measurements will be based on cycle 1 data: 1. Full 3D of one or two bed-position (depending on the size of the participants) SPECT/low dose CT imaging. 2. Whole body planar imaging (fast acquisition using a gamma camera). 3. Blood radioactivity concentration measurements. Please see protocol for further details

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