Brief Summary
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.
Intervention / Treatment
- Drug: 68Ga-R11228
- Drug: 177Lu-R11228
Inclusion Criteria
Part A
- 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.
Part B
- Pathologically confirmed estrogen and/or progesterone receptor (ER/PR) positive and HER2 negative locoregionally recurrent or metastatic breast cancer
- Refractory to endocrine therapy. Note: there is no limit on prior number of lines of endocrine therapy or prior treatments with CDK4/6, AKT, PI3K and/or mTOR inhibitors.
- Received or declined at least one line of chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells or antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses drug conjugate in the locoregionally recurrent or metastatic setting
- Progressive disease or intolerance to last treatment.
- At least one target lesion per RECIST v1.1 criteria.
- Male or non-pregnant, non-lactating female subjects age ≥18 years.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status of 0 or 1.
- Life expectancy of at least six months.
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells reserve, hepatic function and renal function.