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

Phase 1

Not yet recruiting

• Conditions: Somatostatin Receptor Positive; NETs; Lymphoma; Solid Tumor; CNS Tumors; Rhabdomyosarcoma; Peripheral Primitive Neuroectodermal Tumor; GIST

• Registration Number: 2024-512831-66-00
• Lead Sponsor: ITM Solucin GmbH

Brief Summary

Determine the appropriate pediatric dosage based on the safety profile and the pharmacokinetics of lutetium Lu 177 edotreotide targeted radiopharmaceutical therapy (RPT).

Detailed Description

Determine the dose, pharmacokinetics and safety of Lutetium Lu 177 Edotreotide as monotherapy or following sequential standard of care in pediatric participants with recurrent, progressive or refractory NET, CNS, lymphoma and other solid tumors that express SSTRs by immunohistochemistry and demonstrate uptake by somatostatin receptor imaging. Lutetium Lu 177 Edotreotide will be given intravenously once every 8 weeks for a total of up to 6 doses over an average of 48 weeks in participants aged 2-18 years.

Study Timeline

• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-04
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-19
• Primary Completion: 2028-06
• Study Completion: 2034-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pediatric Dosage	a. Dosimetry assessments will be performed at multiple timepoints in cycle 1, 2 and 4. - b. Minimum of eight weeks after the first administration of Lutetium Lu 177 edotreotide	Pediatric dosage based on: 1. absorbed dose by target organs (kidney and bone marrow).; 2. rate of Dose limitting toxicities - based on adverse event reporting.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	At the end of Cycle 2 (each cycle is 28 days)	Assess preliminary anti-tumor activity by tumor type
PK and dosimetry	Dosimetry assessments will be performed at multiple timepoints at Cycle 1, 2 and 4.	Lutetium Lu 177 edotreotide PK evaluation and tumor and target organ dosimetry
Rate of adverse events	From treatment start until 33 days following the last dose of trial treatment or until the End of Last Treatment (EOLT) visit, whichever occurs later..	Safety evaluation of Lutetium Lu 177 edotreotide targeted RPT as monotherapy or following standard of care
Overall Survival, Progression-Free Survival and Duration of Response	Every 9 ± 3 weeks from enrollment until disease progression or for up to two years, whichever came first.	Additional preliminary efficacy evaluation of lutetium Lu 177 Edotreotide targeted RPT as monotherapy or following SoC

Trial Locations

Locations (3)

Fondazione IRCCS Istituto Nazionale Dei Tumori; 🇮🇹 Milan, Italy

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

Fondazione IRCCS Istituto Nazionale Dei Tumori

🇮🇹Milan, Italy

Marta Podda

Site contact

+390223903254

Marta.podda@istitutotumori.mi.it