A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer
Stopped early · Phase 1
Conditions studied: Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer
In brief
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.
Key facts
- Study ID
- NCT07121244
- Run by
- Radionetics Oncology
- People needed
- 11
- Starts
- 2025-10-01
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Part A
- 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.
- Any condition that precludes the proper performance of imaging procedures required in this study.
- Part B
- 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)
- 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 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.
- Any condition that precludes the proper performance of imaging procedures required in this study.
Where it is running
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
- United Theranostics — Glen Burnie, Maryland, United States
- United Theranostics Princeton — Princeton, New Jersey, United States
- University Hospital Seidman Cancer Center — Cleveland, Ohio, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States
- Melbourne Theranostic Innovation Centre (MTIC) — Melbourne, Australia
Full record on ClinicalTrials.gov
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