A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer
Reason given: Sponsor decision
Key facts
- Where
- Cleveland, Glen Burnie, Houston, Indianapolis, Princeton, and Salt Lake City, United StatesSee the 6 sites
- Phase
- Phase 1
Where in United States
- University Hospital Seidman Cancer CenterCleveland, United StatesNo longer taking part
- United TheranosticsGlen Burnie, United StatesNo longer taking part
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, United StatesNo longer taking part
- United Theranostics PrincetonPrinceton, United StatesNo longer taking part
- University of Utah - Huntsman Cancer InstituteSalt Lake City, United StatesNo longer taking part
Trial details
- Who runs it
- Radionetics Oncology
- Trial code
- NCT07121244
- Record updated
- 13 July 2026
- Original description
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.Read full original descriptionShow less
Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Patients With Advanced Breast Cancer
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.
Inclusion: 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 Group (ECOG) Performance Status of 0 or 1; Life expectancy of at least six months; Adequate bone marrow reserve, hepatic function and renal function.
Exclusion: Study participant has not recovered from clinically significant adverse event(s) resulting from most recent anticancer therapy/intervention; 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; Study participant has not recovered from clinically significant adverse event(s) resulting from most recent anticancer therapy/intervention; Treatment with anticancer therapy or with an investigational drug or device within 21 days or 5 half-lives of the agent (whichever is shorter); Prior systemic radionuclide therapeutic treatment; Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R11228; Any unresolved NCI-CTCAE Version 5.0 Grade 2 or higher toxicity (except alopecia and Grade 2 platinum-therapy related neuropathy) from previous breast cancer treatment and/or from medical/surgical procedures or interventions; 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; Any condition that precludes the proper performance of imaging procedures required in this study; Part B; 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; Any condition that precludes the proper performance of imaging procedures required in this study; Part A.