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
| NCT ID | NCT06441331 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ITM Solucin GmbH |
| Condition | Somatostatin Receptor Positive |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-26 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-09-26 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Roman Henkel, PhD
STUDY DIRECTOR
Director, Global Clinical Operations
Frequently Asked Questions
Who can join the NCT06441331 clinical trial?
This trial is open to participants of all sexes, aged 24 Months or older, up to 18 Years, studying Somatostatin Receptor Positive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06441331 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06441331 currently recruiting?
Yes, NCT06441331 is actively recruiting participants. Contact the research team at kinlet@itm-radiopharma.com for enrollment information.
Where is the NCT06441331 trial being conducted?
This trial is being conducted at Philadelphia, United States, Houston, United States, Villejuif, France, Barcelona, Spain and 1 additional location.
Who is sponsoring the NCT06441331 clinical trial?
NCT06441331 is sponsored by ITM Solucin GmbH. The principal investigator is Roman Henkel, PhD at Director, Global Clinical Operations. The trial plans to enroll 20 participants.