Actively Recruiting
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
Led by ITM Solucin GmbH · Updated on 2026-05-01
20
Participants Needed
5
Research Sites
444 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 69 2 years and < 18 years
- Confirmed diagnosis of somatostatin receptor-positive (SSTR-positive) disease
- Tumor that is relapsed or refractory to at least one previous therapy
- Positive SSTR expression confirmed by immunohistochemistry of tumor sample
- Tumor uptake higher than liver on somatostatin receptor imaging (SPECT/CT or PET/CT)
- Recovery from acute treatment-related toxicities to grade 69 1 (excluding alopecia, stable treated electrolyte abnormalities, and stable treated hypothyroidism)
- Washout period completed if sequential treatment followed by standard of care prior to targeted RPT
- Participant or legal guardian willing to sign screening consent, assent obtained when appropriate
You will not qualify if you...
- Known allergy to Lutetium Lu 177 Edotreotide, DOTA/Edotreotide, or excipients
- History of acute leukemia unless in remission for at least 2 years
- Extensive bone or bone marrow involvement unless sufficient peripheral blood stem cells are available
- Prior systemic targeted radiopharmaceutical therapy
- Previous metaiodobenzyl guanidine (MIBG) treatment exceeding safety exposure limits to bone marrow or kidney
- Prior external beam radiation therapy exceeding safety exposure limits to bone marrow or kidney
- Previous treatment with oncologic immune vaccine or CAR-T cell therapy
- Large disease in the central nervous system
- Severe kidney, liver, electrolyte, heart, or blood problems
- Receipt of live-attenuated vaccine within 4 weeks before enrollment
- Pregnancy or breastfeeding
- Presence of other known cancers
- Serious non-malignant diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Serhii Melnyk, MD
CONTACT
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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