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A Phase 1, Non-Randomized, Open-Label, Dose Escalation, Single-Center Study to Determine the Safety, Bio-distribution, and Preliminary Effectiveness of AlphaMedix™ in Adult Subjects With SSRT(+) NETs

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Trial Profile

A Phase 1, Non-Randomized, Open-Label, Dose Escalation, Single-Center Study to Determine the Safety, Bio-distribution, and Preliminary Effectiveness of AlphaMedix™ in Adult Subjects With SSRT(+) NETs

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 15 Feb 2024

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At a glance

  • Drugs ORM 2110 (Primary)
  • Indications Neuroendocrine tumours
  • Focus Adverse reactions; First in man
  • Sponsors RadioMedix

    • Most Recent Events

    • 12 Feb 2024 According to a RadioMedix media release, the United States FDA has granted Breakthrough Therapy Designation to AlphaMedixTM (212Pb-DOTAMTATE) for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumors who are naive to peptide receptor radionuclide therapy based on results from phase 1 and the ongoing phase 2 clinical trials that assessed the safety and efficacy of AlphaMedixTM.
    • 01 Sep 2022 Interim Results(n=20) of the phase 1 first-in-humans dose-escalation trial evaluating 212Pb-DOTAMTATE (a bifunctional metal chelator and the SSTR-targeting peptide in patients with somatostatin receptor-positive Neuroendocrine Tumorsspublished in the Journal of Nuclear Medicine
    • 07 Jun 2022 Results (n=11; as of Jan 2022) reporting safety and efficacy data presented at the 58th Annual Meeting of the American Society of Clinical Oncology
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