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 (May 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
Cancer type
Non-Hodgkin Lymphoma
Tumor Agnostic
Rhabdomyosarcoma
Glioblastoma
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)
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
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