RecruitingPhase 1NCT07121244
A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer
Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Patients With Advanced Breast Cancer
Sponsor
Radionetics Oncology
Enrollment
62 participants
Start Date
Oct 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.
Eligibility
Min Age: 18 Years
Inclusion Criteria14
- 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 Criteria15
- 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.
Interventions
DRUG68Ga-R11228
68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
DRUG177Lu-R11228
177Lu-R11228 is a lutetium-labeled small molecule radioligand designed to treat tumor lesions
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07121244