A Phase I, Multicenter, Open-Label Dosimetry Study Of I-131-Clr1404 In Patients With Relapsed Or Refractory Advanced Solid Tumors Who Have Failed Standard Therapy Or For Whom No Standard Therapy Exists.

e13116 Background: I-131-CLR1404 is a small-molecule, iodophenyl-containing phospholipid ether analog that selectively delivers a cytotoxic beta-emitting radioisotope to cancer cells. In human tumor xenograft models, I-131-CLR1404 slowed malignant tumor growth and extended survival. Methods: A multi-center study evaluating total body and organ dosimetry, safety, and pharmacokinetics of 131-I-CLR1404 was conducted in 8 subjects with refractory solid tumors. We sought to determine the millicurie (mCi) dose of I-131-CLR1404 expected to deliver 35-40 centigray (cGy) to marrow, which will serve as the starting dose in a subsequent maximum tolerated dose (MTD) study. Subjects received a single dose of 10 mCi of I-131-CLR1404. Serial whole body planar scintigraphy images were obtained from 15 minutes to 6 days after I-131-CLR1404. Blood and urine samples were for biodistribution and pharmacokinetics. Results: Dosimetry calculations demonstrated consistency of organ and total body dosimetry in the 8 subjects. SPE...