A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer

July 9, 2026 updated by: Radionetics Oncology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Melbourne, Australia
        • Melbourne Theranostic Innovation Centre (MTIC)
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • United Theranostics
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • United Theranostics Princeton
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospital Seidman Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah - Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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 Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: 68Ga-R11228 Dose Optimization Portion
68Ga-R11228 injection at pre-defined dose levels.
Drug: 68Ga-R11228
68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
Experimental: 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.
Drug: 68Ga-R11228
68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
Drug: 177Lu-R11228
177Lu-R11228 is a lutetium-labeled small molecule radioligand designed to treat tumor lesions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 1 to Day 7
Incidence of Serious Adverse Events [68Ga-R11228]
Time Frame: Day 1 to Day 7
Number of participants with serious adverse events
Day 1 to Day 7
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
Day 1 to week 36
Incidence of Serious Adverse Events [177Lu-R11228]
Time Frame: Day 1 to week 36
Number of participants with serious adverse events
Day 1 to week 36
Incidence of dose limiting toxicities [177Lu-R11228]
Time Frame: Day 1 to week 36
Number of participants with dose limiting toxicities
Day 1 to week 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Image quality
Time Frame: Day 1
68Ga-R11228 positron emission tomography (PET) image quality as assessed by a 5-point Likert scale
Day 1
Absorbed dose coefficients [68Ga-R11228]
Time Frame: Day 1
Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs.
Day 1
Standardized uptake value in tumor lesions [68Ga-R11228]
Time Frame: Day 1
Standard uptake value (SUV) in tumor lesions
Day 1
Effective whole-body dose for 68Ga-R11228
Time Frame: Day 1
Effective whole-body dose (millisievert [mSv]/MBq) for 68Ga-R11228
Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time Frame: Day 1
PK parameters, including Cmax
Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time Frame: Day 1
PK parameters, including area under the curve
Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time Frame: Day 1
PK parameters, including half-life
Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time Frame: Day 1
PK parameters, including total plasma clearance
Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time Frame: Day 1
PK parameters, including apparent volume of distribution
Day 1
Pharmacokinetic parameters of 68Ga-R11228
Time Frame: Day 1
Amount of 68Ga-R11228 excreted in urine
Day 1
Inter-reader agreement
Time Frame: Day 1
Inter-reader agreement described by Fleiss' kappa coefficient
Day 1
Intra-reader reproducibility
Time Frame: Day 1
Intra-reader reproducibility described by Cohen's kappa coefficient
Day 1
Number of study participants with at least one tumor lesion detected
Time Frame: Day 1
Number of study participants with at least one tumor lesion detected by imaging with 68Ga-R11228
Day 1
Proportion of tumor lesions detected by imaging with 68Ga-R11228 per study participant
Time Frame: Day 1
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
Day 1
Absorbed dose coefficients [177Lu-R11228]
Time Frame: 7 days
Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs and tumor lesions for 177Lu-R11228
7 days
Pharmacokinetic parameters of 177Lu-R11228
Time Frame: 7 days
PK parameters, including Cmax
7 days
Pharmacokinetic parameters of 177Lu-R11228
Time Frame: 7 days
PK parameters, including area under the curve
7 days
Pharmacokinetic parameters of 177Lu-R11228
Time Frame: 7 days
PK parameters, including half-life
7 days
Pharmacokinetic parameters of 177Lu-R11228
Time Frame: 7 days
PK parameters, including total plasma clearance
7 days
Pharmacokinetic parameters of 177Lu-R11228
Time Frame: 7 days
PK parameters, including apparent volume of distribution
7 days
Objective response rate
Time Frame: 36 weeks
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
36 weeks
Duration of response
Time Frame: 36 weeks
Time from achieving partial response or complete response to progression per RECIST v1.1 or death, whichever is sooner
36 weeks
Progression free survival
Time Frame: 36 weeks
Time from first 177Lu-R11228 dose until progression per RECIST v1.1 or death, whichever is sooner
36 weeks
Overall survival
Time Frame: 36 weeks
Time from first 177Lu-R11228 dose until death from any cause
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radionetics Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R11228-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings