drugset / Trial / NCT06441331

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

NCT06441331 ↗

Phase 1 Recruiting 20 enrolled ITM Solucin GmbH
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-26
Primary completion
2028-06
Completion
2034-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Lutetium Lu 177-Edotreotide Peptide 100 mbq/kg Intravenous