NCT07121244 A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer
| NCT ID | NCT07121244 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Radionetics Oncology |
| Condition | Locoregionally Recurrent Hormone-receptor Positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-06-01 |
Trial Parameters
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Brief Summary
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.
Eligibility Criteria
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 chemotherapy or antibody 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 Oncology G
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