Phase 1 Study of CLR 125 in Triple Negative Breast Cancer

This study is designed to determine the recommended dose and regimen for future trials and to evaluate the safety and tolerability of CLR 125 at the selected doses in patients with advanced triple negative breast cancer. It will also determine the antitumor activity (treatment response by RECIST v1.1) through assessment of overall response rate, progression free survival, overall survival, duration of response and duration of clinical benefit of CLR 125 in patients with advanced triple negative breast cancer. Total body, organ, and tumor dosimetry will be assessed in a select number of patients prior to CLR 125 dosing. At the conclusion of the study, total body, organ, and tumor dosimetry will be calculated for the intended patient population, to inform future studies. Up to 60 evaluable patients will be enrolled.