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 (KinLET)

April 27, 2026 updated by: ITM Solucin GmbH

A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4319
        • Recruiting
        • The Children's Hospital of Philadelphia (CHOP)
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas - MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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 Names:
  • 177Lu-edotreotide
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.
Other Names:
  • Arginine-Lysine Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: At the end of Cycle 2 (each cycle is 28 days)
Assess preliminary anti-tumor activity by tumor type
At the end of Cycle 2 (each cycle is 28 days)
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
Every 9 ± 3 weeks from enrollment until disease progression or for up to two years, whichever came first.
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
Dosimetry assessments will be performed at multiple timepoints at Cycle 1, 2 and 4.
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
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..

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Endpoint: Quality of Life
Time Frame: At enrollment, 18 days prior to cycles 2-6, four ± 3 weeks after targeted RPT.
Assess quality of life based on the adapted Quality of Life (QoL) scale (PedsQL TM 3.0 Cancer Module)
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
Time Frame: No timeframe given.
Correlation of the expression level of SSTR immunohistochemistry in tumor biopsy or surgery samples and 111In-based, 99mTc-based, or 68Ga-based-based lesion uptake (regarding intensity/distribution)
No timeframe given.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ITM Solucin GmbH

Investigators

  • Study Director: Roman Henkel, PhD, Director, Global Clinical Operations

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

April 1, 2034

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITM-1191-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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