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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
ITM Solucin GmbH
Study ID
NCT06441331
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
24 Months - 18 Years
Healthy Volunteers
Not accepted

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
  • 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.

Study Details

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.

Key Dates

Start date
Sep 26, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Apr 30, 2034

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

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

Locations (2)

FacilityCityStateZIPSite coordinators
The Children's Hospital of Philadelphia (CHOP)PhiladelphiaPennsylvania19104-4319
Theodore W. Laetsch, MD
[email protected]
University of Texas - MD Anderson Cancer CenterHoustonTexas77030
David McCall, MD
[email protected]

Find similar trials in Philadelphia, PA

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
The Children's Hospital of Philadelphia (CHOP)· Philadelphia, PAUniversity of Texas - MD Anderson Cancer Center· Houston, TX

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