Actively Recruiting
A Multicenter, Open-label Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy for Somatostatin Receptor-positive Tumors in Children
Led by ITM Solucin GmbH · Updated on 2026-05-01
20
Participants Needed
5
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find the right pediatric dose and study the safety and how the body processes Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) in children aged 2 to under 18 years who have tumors that show somatostatin receptor positivity. The study includes children with neuroendocrine tumors (NET), central nervous system tumors, lymphoma, and other solid tumors that have returned, grown, or not responded to previous treatments. Lutetium Lu 177 Edotreotide will be given by intravenous infusion every 8 weeks for up to 6 doses over about 48 weeks. Participants are grouped by age: 12 to under 18 years, 6 to under 12 years, and 2 to under 6 years. The dose for each group will be decided based on safety and dosimetry data from earlier groups. An amino acid solution containing lysine and arginine is also used in the study. During the study, participants will have dosimetry assessments at various points during treatment cycles 1, 2, and 4, and be monitored for safety including adverse events until 33 days after the last dose. The research team will evaluate the primary outcome of pediatric dosage and secondary outcomes like response to treatment, pharmacokinetics, survival, and duration of response. Participants will be followed for up to two years or until disease progression. The study is open-label and involves regular visits for treatment and monitoring.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 2 years and under 18 years
- Confirmed diagnosis of somatostatin receptor-positive disease
- Tumor relapsed or refractory to at least one prior therapy
- Positive somatostatin receptor protein expression confirmed by tumor immunohistochemistry
- Tumor uptake higher than liver uptake shown by somatostatin receptor imaging
- Recovery from acute treatment-related toxicities to grade 1 or better before enrollment
- Willingness of participant or legal guardian to sign screening consent, with assent as appropriate
You will not qualify if you...
- Known allergy to Lutetium Lu 177 Edotreotide, DOTA/Edotreotide, or related substances
- History of acute leukemia unless in remission for at least two years
- Extensive bone or bone marrow involvement unless sufficient peripheral blood stem cells are available
- Previous systemic targeted radiopharmaceutical therapy
- Prior treatment with MIBG exceeding safe bone marrow or kidney exposure limits
- Prior external beam radiation therapy exceeding safe bone marrow or kidney exposure limits
- Previous oncologic immune vaccine or CAR-T cell therapy
- Large tumor burden in the central nervous system
- Severe kidney, liver, electrolyte, heart, or blood dysfunction
- Receipt of live-attenuated vaccine within four weeks before enrollment
- Pregnant or breastfeeding females
- Presence of other known malignancies
- Serious non-malignant diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 to 48 weeks
Participants receive intravenous Lutetium Lu 177 Edotreotide once every 8 weeks for up to 6 doses, with dosing decisions guided by safety and dosimetry data. Amino Acid Solution is administered as part of the protocol.
Up to 6 visits every 8 weeks (in-person)
Duration - Up to 2 years
Participants are monitored for adverse events and overall health, including survival and disease progression, every 9 ± 3 weeks for up to two years after treatment ends.
Visits approximately every 9 weeks (in-person)
Trial Site Locations
Total: 5 locations
1
The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States, 19104-4319
Actively Recruiting
2
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
Gustave Roussy Cancer Campus
Villejuif, France, 94800
Actively Recruiting
4
Hospital Universitario Vall d'Hebron - Oncología Médica
Barcelona, Spain, 08035
Actively Recruiting
5
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28009
Actively Recruiting
Research Team
S
Shahanaz Rahman
S
Serhii Melnyk, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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