Recruiting
Phase 1

Lutetium Lu 177 Edotreotide

Sponsor:

ITM Solucin GmbH

Code:

NCT06441331

Conditions

Somatostatin Receptor Positive

NETs

Lymphoma

Solid Tumor

CNS Tumors

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Lutetium Lu 177-Edotreotide

Amino Acid Solution

Study Details

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

Study ID

NCT06441331

Start date

Sep 26, 2025

Status verified date

Apr, 2026

Completion date

Apr, 2034

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Shahanaz Rahman

+4989 32989866000kinlet@itm-radiopharma.com

Serhii Melnyk, MD

kinlet@itm-radiopharma.com

Locations

UCSF Benioff Children's Hospital

Recruiting

San Francisco, California, United States, 94158

Contacts

Kieuhoa T. Vo, MD

(415) 476-3831kieuhoa.vo@ucsf.edu

The Children's Hospital of Philadelphia (CHOP)

Recruiting

Philadelphia, Pennsylvania, United States, 19104-4319

Contacts

Theodore W. Laetsch, MD

laetscht@chop.edu

University of Texas - MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

David McCall, MD

dmccall1@mdanderson.org

More Information

Sponsor

ITM Solucin GmbH

Last update posted

Aug 4, 2026

Last verified

Apr, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by ITM Solucin GmbH on 2026-08-04.