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

摘要: This study explores the imaging and therapeutic properties of a novel radiopharmaceutical, (131)I-CLR1404. Phase 1a data demonstrated safety tumor localization by SPECT-CT. 1b assessed safety, characteristics, possible antineoplastic provided further proof-of-concept phospholipid ether analogues' retention within tumors. A total 10 patients received (131)I-CLR1404 in an adaptive dose-escalation design. Imaging characteristics were consistent with prior studies, showing uptake primary tumors metastases. At doses 31.25 mCi/m(2) greater, DLTs thrombocytopenia neutropenia. Disease-specific studies are underway to identify cancers most likely benefit from monotherapy.