A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.
Pathologically confirmed estrogen and/or progesterone receptor (ER/PR) positive and HER2 negative locoregionally recurrent or metastatic breast cancer
At least one target or non-target lesion per RECIST v1.1 criteria.
Male or non-pregnant, non-lactating female subjects age ≥18 years.
Pathologically confirmed estrogen and/or progesterone receptor (ER/PR) positive and HER2 negative locoregionally recurrent or metastatic breast cancer
Study participant has not recovered from clinically significant adverse event(s) resulting from most recent anticancer therapy/intervention.
Known central nervous system (CNS) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period.
Radiotherapy for breast cancer ≤ 28 days prior
Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R11228.
Radionetics Oncology
Lead sponsor