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Recruiting Phase 1

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 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2025-09-26
Last updated
2026-10-27

Condition(s) studied

Somatostatin Receptor PositiveNETsLymphomaSolid TumorCNS TumorsRhabdomyosarcomaPeripheral Primitive Neuroectodermal TumorGIST

Investigational drug(s) / intervention(s)

Lutetium Lu 177-Edotreotide →Amino Acid Solution

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

Sex
ALL
Min age
24 Months
Max age
18 Years
Healthy volunteers
No
Key Inclusion Criteria: * Participants aged ≥ 2 years and \< 18 years * Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease. * Tumor which is relapsed or is refractory to at least one line of previous therapy * Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample * Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)/ computed tomography (CT) or positron emission tomography (PET)/CT imaging, which is higher than the liver uptake) * Participants must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria, excluding alopecia, stable treated electrolyte abnormalities on replacement and stable treated hypothyroidism) of all prior treatment modality prior to entering this trial * In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT Screening Consent Participant/legal guardian is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines. Key Exclusion Criteria: * Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA/Edotreotide, or excipients * Previous history of acute leukemia unless in remission for at least two years * Extensive bone/bone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells/kg * Patients who have received previous systemic targeted RPT * Previous treatment with metaiodobenzyl guanidine (MIBG) if the predicted overall exposure is expected to exceed 2 Gy (gray) to the bone marrow or 23 Gy to the kidney. * Previous treatment with external beam radiation therapy (EBRT) if the predicted overall exposure is expected to exceed more than 2 Gy to the bone marrow or 23 Gy to the kidney. * Previous treatment with oncologic immune vaccine or CAR-T cell therapy * Bulky disease in the CNS * Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction * Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment * Pregnant or breastfeeding women. * Other known malignancies. * Serious non-malignant disease.

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)

FacilityCityRegionStatus
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
Official registry record

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