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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

Study acronym: KinLET
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 6 to 7
  2. Eligibility criteria expanded, about 20 words Site details revised at 3 of 6 sites Show 1 more changeShow less
    • Site details revised at 3 of 6 sites
  3. Study sites: 5 to 6v7
  4. Study sites: 2 to 5v6
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Sep 2025 to Sep 26, 2025v5 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 2025 to Sep 26, 2025
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jan 2025 to Sep 2025 Primary endpoint revised · Secondary endpoints: 1 to 4 · Eligibility criteria expanded, about 2 words · 1 morev4 Show 4 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints: 1 to 4
    • Eligibility criteria expanded, about 2 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Sep 2024 to Jan 2025v3
  3. Start date: Jun 2024 to Sep 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06441331
Lead Sponsor ITM Solucin GmbH
Conditions Somatostatin Receptor Positive, NETs, Lymphoma, Solid Tumor, CNS Tumors, Rhabdomyosarcoma, Peripheral Primitive Neuroectodermal Tumor, GIST
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov