A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer
NCT ID: NCT07121244
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
62 participants
INTERVENTIONAL
2025-10-01
2033-06-01
Brief Summary
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Detailed Description
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Part A is being conducted to test 68Ga-R11228, a new investigational product (IP) that has been designed to detect cancer lesions in the body and make them visible on a Positron Emission Tomography (PET) scan. Three dose levels of 68Ga-R11228 will be evaluated, with each patient receiving a single dose.
Part B is being conducted to test 68Ga-R11228 and additionally 177Lu-R11228, which has been designed to treat patients who have cancer lesions with positive uptake on PET scan using 68Ga-R11228. Patients who qualify for 177Lu-R11228 treatment will receive up to 6 doses over approximately 36 weeks. Multiple 177Lu-R11228 dose levels will be evaluated in Part B.
A 5-year Follow-Up Period begins once the last cycle of 177Lu-R11228 dosing is completed.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: 68Ga-R11228 Dose Optimization Portion
68Ga-R11228 injection at pre-defined dose levels.
68Ga-R11228
68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
Part B: 68Ga-R11228 Imaging and 177Lu-R11228 Dose Ranging Portion
68Ga-R11228 injection at pre-defined dose. 177Lu-R11228 injection at pre-defined doses.
68Ga-R11228
68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
177Lu-R11228
177Lu-R11228 is a lutetium-labeled small molecule radioligand designed to treat tumor lesions
Interventions
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68Ga-R11228
68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
177Lu-R11228
177Lu-R11228 is a lutetium-labeled small molecule radioligand designed to treat tumor lesions
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Radionetics Oncology
INDUSTRY
Responsible Party
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Locations
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Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
United Theranostics Princeton
Princeton, New Jersey, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
Melbourne Theranostic Innovation Centre (MTIC)
Melbourne, , Australia
Countries
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Central Contacts
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Facility Contacts
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Ally Stevens
Role: primary
Zinasia Gibson
Role: primary
Blake Nordblad
Role: primary
Chistopher Marinakis
Role: primary
Other Identifiers
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R11228-101
Identifier Type: -
Identifier Source: org_study_id