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A Phase 1, Multi-Center, Open-Label, Dose-Escalation Study of 131I-CLR1404 in Subjects with Relapsed or Refractory Advanced Solid Malignancies.

Abstract
This study explores the imaging and therapeutic properties of a novel radiopharmaceutical, (131)I-CLR1404. Phase 1a data demonstrated safety and tumor localization by SPECT-CT. This 1b study assessed safety, imaging characteristics, and possible antineoplastic properties and provided further proof-of-concept of phospholipid ether analogues' retention within tumors. A total of 10 patients received (131)I-CLR1404 in an adaptive dose-escalation design. Imaging characteristics were consistent with prior studies, showing tumor uptake in primary tumors and metastases. At doses of 31.25 mCi/m(2) and greater, DLTs were thrombocytopenia and neutropenia. Disease-specific studies are underway to identify cancers most likely to benefit from (131)I-CLR1404 monotherapy.
AuthorsSam Joseph Lubner, Jacqueline Mullvain, Scott Perlman, Michael Pishvaian, Joanne Mortimer, Katherine Oliver, Jennifer Heideman, Lance Hall, Jamey Weichert, Glenn Liu
JournalCancer investigation (Cancer Invest) Vol. 33 Issue 10 Pg. 483-9 ( 2015) ISSN: 1532-4192 [Electronic] England
PMID26536061 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • CLR1404
  • Iodobenzenes
  • Phospholipid Ethers
Topics
  • Adult
  • Aged
  • Drug Discovery
  • Female
  • Humans
  • Iodobenzenes (administration & dosage, pharmacology, therapeutic use)
  • Male
  • Middle Aged
  • Neoplasms (drug therapy, radiotherapy)
  • Phospholipid Ethers (administration & dosage, pharmacology, therapeutic use)
  • Recurrence

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