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

NCT06441331 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ITM-1191-01
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 5

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.

Conditions

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

Keywords

Pediatric; CNS tumors; Solid tumors; Lymphoma; Somatostatin Receptor (SSTR)-positive Tumors; Lutetium Lu 177 Edotreotide; Targeted RPT; ITM; GEP-NET; Neuroendocrine tumors; Radiopharmaceutical Therapy; Childhood

Outcome Measures

Primary Outcomes (1)

• Pediatric Dosage

  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.

  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

Secondary Outcomes (4)

• Objective Response Rate

  At the end of Cycle 2 (each cycle is 28 days)

• PK and dosimetry

  Dosimetry assessments will be performed at multiple timepoints at Cycle 1, 2 and 4.

• 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..

• 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.

Other Outcomes (2)

• Exploratory Endpoint: Quality of Life

  At enrollment, 18 days prior to cycles 2-6, four ± 3 weeks after targeted RPT.

• Exploratory Endpoint: Correlation between SSTR expression detected by immunohisto-chemistry and functional imaging

  No timeframe given.

Study Arms (1)

Three sequential age cohorts

EXPERIMENTAL

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

Drug: Lutetium Lu 177-Edotreotide; Other: Amino Acid Solution

Interventions

Lutetium Lu 177-Edotreotide DRUG

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

Also known as: 177Lu-edotreotide

Three sequential age cohorts

Amino Acid Solution OTHER

The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.

Also known as: Arginine-Lysine Solution

Three sequential age cohorts

Eligibility Criteria

• Age: 24 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ITM Solucin GmbH: lead

Study Sites (5)

The Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, 19104-4319, United States

RECRUITING

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Gustave Roussy Cancer Campus

Villejuif, 94800, France

RECRUITING

Hospital Universitario Vall d'Hebron - Oncología Médica

Barcelona, 08035, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28009, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma; Central Nervous System Neoplasms; Rhabdomyosarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Gastro-enteropancreatic neuroendocrine tumor; Neuroendocrine Tumors

Interventions

177Lu-octreotide, DOTA(0)-Tyr(3)-; amino-acid, glucose, and electrolyte solution

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Roman Henkel, PhD

  Director, Global Clinical Operations

  STUDY DIRECTOR

Central Study Contacts

Shahanaz Rahman

CONTACT

+4989 32989866000; kinlet@itm-radiopharma.com

Serhii Melnyk, MD

CONTACT

kinlet@itm-radiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three sequential age cohorts: 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.

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 4, 2024
• Study Start: September 26, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): April 1, 2034
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); ES (2); US (2)