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
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-09-26
2034-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
1. ≥ 12 to \< 18 years old
2. ≥ 6 years to \< 12 years old
3. ≥ 2 to \< 6 years old
A minimum of 20 participants with SSTR-positive tumors of which at least six participants will have gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
A minimum of six participants will be required in each age cohort.
TREATMENT
NONE
Study Groups
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Three sequential age cohorts
Arms are based upon age at enrollment. The opening of the 2nd and 3rd cohort will depend on the recruitment of at least four participants with dosimetry and safety data for cycle 1, in the previous cohort.
1. ≥ 12 to \< 18 years old
2. ≥ 6 years to \< 12 years old
3. ≥ 2 to \< 6 years old
Lutetium Lu 177-Edotreotide
lutetium Lu 177 edotreotide At least two cycles and a maximum of six cycles at eight-week (± 2 we-ek) intervals. Extrapolation from standard maximum adult dose of 100 Megabecquerel(MBq)/kg for a 75 kg adult for the first cohort. Dosing decision for the subsequent cohorts by Data Monitoring Committee (DMC), based on (at least) cycle 1 dosimetry and safety data from at least four participants of the preceding cohort. Route of administration: Intravenous (IV) infusion. Duration of treatment: 16-48 weeks
Amino Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
Interventions
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Lutetium Lu 177-Edotreotide
lutetium Lu 177 edotreotide At least two cycles and a maximum of six cycles at eight-week (± 2 we-ek) intervals. Extrapolation from standard maximum adult dose of 100 Megabecquerel(MBq)/kg for a 75 kg adult for the first cohort. Dosing decision for the subsequent cohorts by Data Monitoring Committee (DMC), based on (at least) cycle 1 dosimetry and safety data from at least four participants of the preceding cohort. Route of administration: Intravenous (IV) infusion. Duration of treatment: 16-48 weeks
Amino Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
24 Months
18 Years
ALL
No
Sponsors
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ITM Solucin GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Roman Henkel, PhD
Role: STUDY_DIRECTOR
Director, Global Clinical Operations
Locations
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The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States
Hospital Universitario Vall d'Hebron - Oncología Médica
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ITM-1191-01
Identifier Type: -
Identifier Source: org_study_id