This is a prospective, Phase I/II multi-center, interventional open-label study in a total of up to 100 subjects with angiogenic breast cancer. Phase I is to assess the safety and adequacy of a dose of HurlutinTM Lu-177 for up to two cycles, at 6-8-week intervals. It will include a dose expansion cohort of up to 20 patients. Phase II is to demonstrate the safety, dose adequacy, anti-tumor activity and efficacy of tumor targeted therapy using Lutetium-177-DOTAGA-PEG-IAC , as a second- or third-line treatment to extend survival and improve the quality of life of patients with angiogenic breast cancer.
This study is a Phase I/II clinical evaluation of a new investigational agent, Lutetium-177-DOTAGA-PEG-IAC (HurlutinTM Lu-177) to treat patients with unresectable angiogenic breast cancer who have previously been treated with at least one prior line of therapy.