Current partner codePEPTIDESDE
NCT06441331·Phase 1·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 1

Enrollment

20

Locations

5

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

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

OTHER

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.

Timeline

From registration to results.

  1. First posted

    Jun 4, 2024

  2. Study start

    Sep 26, 2025

  3. Primary completion

    Jun 2028

  4. Study completion

    Apr 2034

  5. Results posted

    Not reported

  6. Registry updated

    May 1, 2026

Outcomes

What the study measures.

Primary outcomes

Pediatric Dosage

Time frame · 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 outcomes

Objective Response Rate

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

Assess preliminary anti-tumor activity by tumor type

PK and dosimetry

Time frame · 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

Time frame · 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

Time frame · 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

Eligibility

Who can take part.

Minimum age
24 Months
Maximum age
18 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

5 registered sites.

France · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.

The Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Gustave Roussy Cancer Campus

Villejuif, France

Hospital Universitario Vall d'Hebron - Oncología Médica

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Octreotide.

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Put the record in context.

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