OncoMatch/Clinical Trials/NCT06441331
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
Is NCT06441331 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Lutetium Lu 177-Edotreotide for somatostatin receptor positive.
Treatment: Lutetium Lu 177-Edotreotide — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Cancer type
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Tumor Agnostic
Rhabdomyosarcoma
Sarcoma
Gastrointestinal Stromal Tumor
Biomarker criteria
Required: SSTR overexpression (positive SSTR protein expression confirmed by immunohistochemistry)
Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample
Required: SSTR imaging uptake higher than liver (radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs (111In-based, 99mTc-based, or 68Ga-based SSTR SPECT/CT or PET/CT imaging, which is higher than the liver uptake))
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)
Demographics
Prior therapy
Must have received: any prior therapy
Tumor which is relapsed or is refractory to at least one line of previous therapy
Cannot have received: systemic targeted RPT
Patients who have received previous systemic targeted RPT
Cannot have received: metaiodobenzyl guanidine (MIBG) therapy
Exception: 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 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.
Cannot have received: external beam radiation therapy
Exception: 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 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.
Cannot have received: oncologic immune vaccine
Previous treatment with oncologic immune vaccine
Cannot have received: CAR-T cell therapy
Previous treatment with...CAR-T cell therapy
Lab requirements
Blood counts
Presence of severe hematological dysfunction [excluded]
Kidney function
Presence of severe renal dysfunction [excluded]
Liver function
Presence of severe hepatic dysfunction [excluded]
Cardiac function
Presence of severe cardiovascular dysfunction [excluded]
Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Children's Hospital of Philadelphia (CHOP) · Philadelphia, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06441331 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic targeted RPT, metaiodobenzyl guanidine (MIBG) therapy, external beam radiation therapy disqualifies patients from enrollment.
Does this trial require SSTR?
Yes, SSTR overexpression is a required biomarker for enrollment.
Does this trial require SSTR?
Yes, SSTR imaging uptake higher than liver is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 18 years or younger and at least 2 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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