title: 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.
authors.affiliation: a University of Wisconsin Carbone Cancer Center , Madison , WI , USA.
authors.forename: Sam Joseph
authors.initials: SJ
authors.lastname: Lubner
authors.affiliation: a University of Wisconsin Carbone Cancer Center , Madison , WI , USA.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Mullvain
authors.affiliation: a University of Wisconsin Carbone Cancer Center , Madison , WI , USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Perlman
authors.affiliation: b Georgetown University Medical Center , Lombardi Cancer Center, Washington, DC , USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Pishvaian
authors.affiliation: c City of Hope Comprehensive Cancer Center , Duarte , CA , USA.
authors.forename: Joanne
authors.initials: J
authors.lastname: Mortimer
authors.affiliation: d Cellectar Biosciences , Madison , WI , USA.
authors.forename: Katherine
authors.initials: K
authors.lastname: Oliver
authors.affiliation: a University of Wisconsin Carbone Cancer Center , Madison , WI , USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Heideman
authors.affiliation: a University of Wisconsin Carbone Cancer Center , Madison , WI , USA.
authors.forename: Lance
authors.initials: L
authors.lastname: Hall
authors.affiliation: a University of Wisconsin Carbone Cancer Center , Madison , WI , USA.|d Cellectar Biosciences , Madison , WI , USA.
authors.forename: Jamey
authors.initials: J
authors.lastname: Weichert
authors.affiliation: a University of Wisconsin Carbone Cancer Center , Madison , WI , USA.
authors.forename: Glenn
authors.initials: G
authors.lastname: Liu
mesh_terms: D000328:Adult; D000368:Aged; D055808:Drug Discovery; D005260:Female; D006801:Humans; D007462:Iodobenzenes / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D010742:Phospholipid Ethers / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D012008:Recurrence
chemical_list: C000599353:CLR1404; D007462:Iodobenzenes; D010742:Phospholipid Ethers
keywords: Drug discovery; Phase 1; Radiotherapy; Targeted therapy