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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Pediatric Dosage — a. Dosimetry assessments will be performed at multiple timepoints in cycle 1, 2 and 4. - b. Minimum of eight weeks after the first administration of Lutetium Lu 177 edotreotide
Pediatric dosage based on: 1. absorbed dose by target organs (kidney and bone marrow). 2. rate of Dose limitting toxicities - based on adverse event reporting.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Lucile Packard Children's Hospital at Stanford | Palo Alto | California | Recruiting |
| UCSF Benioff Children's Hospital | San Francisco | California | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | Recruiting |
| The Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | Recruiting |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | Recruiting |
| CHU de Marseille - Hôpital de la Timone | Marseille | France | Recruiting |
| Gustave Roussy Cancer Campus | Villejuif | France | Recruiting |
| Hospital Universitario Vall d'Hebron - Oncología Médica | Barcelona | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06441331 on ClinicalTrials.gov ↗ ← All trials in the USA