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ORIGINAL ARTICLE

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

, , , , , , , , & show all
Pages 483-489 | Received 30 Jun 2015, Accepted 06 Aug 2015, Published online: 04 Nov 2015
 

Abstract

This study explores the imaging and therapeutic properties of a novel radiopharmaceutical, 131I-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 131I-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/m2 and greater, DLTs were thrombocytopenia and neutropenia. Disease- specific studies are underway to identify cancers most likely to benefit from 131I-CLR1404 monotherapy.

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