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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

April 30, 2034

Conditions
Somatostatin Receptor PositiveNETsLymphomaSolid TumorCNS TumorsRhabdomyosarcomaPeripheral Primitive Neuroectodermal TumorGIST
Interventions
DRUG

Lutetium Lu 177-Edotreotide

lutetium 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

OTHER

Amino Acid Solution

The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.

All Listed Sponsors
lead

ITM Solucin GmbH

INDUSTRY