Phase I Trial to Determine the Dose and Evaluate the PK of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors — KinLET  

Lymphoma Clinical Trial

Official title: 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).

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• CNS Tumor
• Lymphoma
• Neoplasms
• NET
• Solid Tumor, Childhood
• Somatostatin Receptor Positive

• NCT number: NCT06441331
• Study type: Interventional
• Source: ITM Solucin GmbH
• Contact: Shahanaz Rahman
• Phone: 089 32989866000
• Email: info-solucin@itm-radiopharma.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Completion date: April 2034