Locoregionally Recurrent Hormone-receptor Positive Breast CancerPhase 1NCT07121244
A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer
A Phase 1 study testing 68Ga-R11228 and 177Lu-R11228 in people with Locoregionally Recurrent Hormone-receptor Positive Breast Cancer and Metastatic Hormone Receptor Positive Breast Cancer, run by Radionetics Oncology at 7 sites in 2 countries.
Trial summary
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer
- What is being tested?
- 68Ga-R11228 and 177Lu-R11228
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 Oct 2025to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
University Hospital Seidman Cancer Center
Cleveland, Ohio, 44106
United Theranostics
Glen Burnie, Maryland, 21061
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United Theranostics Princeton
Princeton, New Jersey, 08540
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: 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.
Read the detailed description
Patients with metastatic or locoregionally recurrent ER+ and/or PR+ and HER2 negative breast cancer will be enrolled.
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
- Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer
- Being tested
- 68Ga-R11228, 177Lu-R11228
- Keywords
- Hormone Receptor Positive Breast Cancer, Endocrine resistant, Radioisotope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-R11228Drug
68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
177Lu-R11228Drug
177Lu-R11228 is a lutetium-labeled small molecule radioligand designed to treat tumor lesions
| Study group | Role | What they receive |
|---|---|---|
| Part A: 68Ga-R11228 Dose Optimization Portion | Experimental | 68Ga-R11228 injection at pre-defined dose levels. Receives: Drug: 68Ga-R11228 |
| Part B: 68Ga-R11228 Imaging and 177Lu-R11228 Dose Ranging Portion | Experimental | 68Ga-R11228 injection at pre-defined dose. 177Lu-R11228 injection at pre-defined doses. Receives: Drug: 68Ga-R11228; Drug: 177Lu-R11228 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events [68Ga-R11228]
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Measured: Day 1 to Day 7
Incidence of Serious Adverse Events [68Ga-R11228]
Number of participants with serious adverse events
Measured: Day 1 to Day 7
Incidence of adverse events [177Lu-R11228]
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Measured: Day 1 to week 36
Incidence of Serious Adverse Events [177Lu-R11228]
Number of participants with serious adverse events
Measured: Day 1 to week 36
Incidence of dose limiting toxicities [177Lu-R11228]
Number of participants with dose limiting toxicities
Measured: Day 1 to week 36
Secondary outcomes (24)
Image quality
68Ga-R11228 positron emission tomography (PET) image quality as assessed by a 5-point Likert scale
Measured: Day 1
Absorbed dose coefficients [68Ga-R11228]
Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs.
Measured: Day 1
Standardized uptake value in tumor lesions [68Ga-R11228]
Standard uptake value (SUV) in tumor lesions
Measured: Day 1
Effective whole-body dose for 68Ga-R11228
Effective whole-body dose (millisievert [mSv]/MBq) for 68Ga-R11228
Measured: Day 1
Pharmacokinetic parameters of 68Ga-R11228
PK parameters, including Cmax
Measured: Day 1
Pharmacokinetic parameters of 68Ga-R11228
PK parameters, including area under the curve
Measured: Day 1
Pharmacokinetic parameters of 68Ga-R11228
PK parameters, including half-life
Measured: Day 1
Pharmacokinetic parameters of 68Ga-R11228
PK parameters, including total plasma clearance
Measured: Day 1
Pharmacokinetic parameters of 68Ga-R11228
PK parameters, including apparent volume of distribution
Measured: Day 1
Pharmacokinetic parameters of 68Ga-R11228
Amount of 68Ga-R11228 excreted in urine
Measured: Day 1
Inter-reader agreement
Inter-reader agreement described by Fleiss' kappa coefficient
Measured: Day 1
Intra-reader reproducibility
Intra-reader reproducibility described by Cohen's kappa coefficient
Measured: Day 1
Number of study participants with at least one tumor lesion detected
Number of study participants with at least one tumor lesion detected by imaging with 68Ga-R11228
Measured: Day 1
Proportion of tumor lesions detected by imaging with 68Ga-R11228 per study participant
Proportion of the number of tumor lesions positive with 68Ga-11228 imaging divided by the number of tumor lesions detected with standard of care images
Measured: Day 1
Absorbed dose coefficients [177Lu-R11228]
Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs and tumor lesions for 177Lu-R11228
Measured: 7 days
Pharmacokinetic parameters of 177Lu-R11228
PK parameters, including Cmax
Measured: 7 days
Pharmacokinetic parameters of 177Lu-R11228
PK parameters, including area under the curve
Measured: 7 days
Pharmacokinetic parameters of 177Lu-R11228
PK parameters, including half-life
Measured: 7 days
Pharmacokinetic parameters of 177Lu-R11228
PK parameters, including total plasma clearance
Measured: 7 days
Pharmacokinetic parameters of 177Lu-R11228
PK parameters, including apparent volume of distribution
Measured: 7 days
Objective response rate
Number of study participants with a complete or partial response divided by the number of study participants who had at least one 177Lu-11228 dose
Measured: 36 weeks
Duration of response
Time from achieving partial response or complete response to progression per RECIST v1.1 or death, whichever is sooner
Measured: 36 weeks
Progression free survival
Time from first 177Lu-R11228 dose until progression per RECIST v1.1 or death, whichever is sooner
Measured: 36 weeks
Overall survival
Time from first 177Lu-R11228 dose until death from any cause
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Oct 2025
- Primary completion1 Jun 2026
- Study completion30 Jun 2026
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locoregionally Recurrent Hormone-receptor Positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radionetics Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121244
- Sponsor's protocol ID
- R11228-101
- Status last verified
- Apr 2026
- First submitted
- 6 Aug 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07121244
- Acronym / sponsor ID
- R11228-101
- Conditions
- Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer
- Keywords
- Hormone Receptor Positive Breast Cancer, Endocrine resistant, Radioisotope
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Radionetics OncologyIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.
Detailed description
Patients with metastatic or locoregionally recurrent ER+ and/or PR+ and HER2 negative breast cancer will be enrolled.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: 68Ga-R11228 Dose Optimization Portion | Experimental | Drug: 68Ga-R1122868Ga-R11228 injection at pre-defined dose levels. |
| Part B: 68Ga-R11228 Imaging and 177Lu-R11228 Dose Ranging Portion | Experimental | Drug: 68Ga-R11228, Drug: 177Lu-R1122868Ga-R11228 injection at pre-defined dose. 177Lu-R11228 injection at pre-defined doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-R1122868Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions | Drug | Part A: 68Ga-R11228 Dose Optimization Portion, Part B: 68Ga-R11228 Imaging and 177Lu-R11228 Dose Ranging Portion |
| 177Lu-R11228177Lu-R11228 is a lutetium-labeled small molecule radioligand designed to treat tumor lesions | Drug | Part B: 68Ga-R11228 Imaging and 177Lu-R11228 Dose Ranging Portion |
Primary outcome
Incidence of adverse events [68Ga-R11228]
Time frame: Day 1 to Day 7
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Incidence of Serious Adverse Events [68Ga-R11228]
Time frame: Day 1 to Day 7
Number of participants with serious adverse events
Incidence of adverse events [177Lu-R11228]
Time frame: Day 1 to week 36
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Incidence of Serious Adverse Events [177Lu-R11228]
Time frame: Day 1 to week 36
Number of participants with serious adverse events
Incidence of dose limiting toxicities [177Lu-R11228]
Time frame: Day 1 to week 36
Number of participants with dose limiting toxicities
24 secondary outcomes
Image quality
Time frame: Day 1
Absorbed dose coefficients [68Ga-R11228]
Time frame: Day 1
Standardized uptake value in tumor lesions [68Ga-R11228]
Time frame: Day 1
Effective whole-body dose for 68Ga-R11228
Time frame: Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time frame: Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time frame: Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time frame: Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time frame: Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time frame: Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time frame: Day 1
Inter-reader agreement
Time frame: Day 1
Intra-reader reproducibility
Time frame: Day 1
Number of study participants with at least one tumor lesion detected
Time frame: Day 1
Proportion of tumor lesions detected by imaging with 68Ga-R11228 per study participant
Time frame: Day 1
Absorbed dose coefficients [177Lu-R11228]
Time frame: 7 days
Pharmacokinetic parameters of 177Lu-R11228
Time frame: 7 days
Pharmacokinetic parameters of 177Lu-R11228
Time frame: 7 days
Pharmacokinetic parameters of 177Lu-R11228
Time frame: 7 days
Pharmacokinetic parameters of 177Lu-R11228
Time frame: 7 days
Pharmacokinetic parameters of 177Lu-R11228
Time frame: 7 days
Objective response rate
Time frame: 36 weeks
Duration of response
Time frame: 36 weeks
Progression free survival
Time frame: 36 weeks
Overall survival
Time frame: 36 weeks
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-R11228 and 177Lu-R11228 in people with Locoregionally Recurrent Hormone-receptor Positive Breast Cancer and Metastatic Hormone Receptor Positive Breast Cancer, run by Radionetics Oncology at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events [68Ga-R11228] (time frame: Day 1 to Day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.