Cellectar submits a protocol with U.S. FDA for Phase 1b Dose Finding study

Cellectar Biosciences (CLRB) announced that the company has submitted a protocol with the U.S. Food and Drug Administration, FDA, for a Phase 1b Dose Finding study of its Auger emitting radiopharmaceutical, CLR 125, for the treatment of relapsed TNBC. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers. The proposed Phase 1b dose finding study in relapsed TNBC will utilize imaging to determine tumor uptake to evaluate three doses of CLR 125 with four doses per cycle in 15 patients per arm. The primary endpoint of the study will be to determine the recommended Phase 2 dose and dosing regimen and will also evaluate safety and tolerability, as well as initial response assessment.