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A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07121244•Radionetics Oncology

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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.
+5 more criteria

Locations (7)

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

Key Dates

Start Date

October 1, 2025

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2033

Last Updated

March 9, 2026

Enrollment

ESTIMATED participants

Conditions

Locoregionally Recurrent Hormone-receptor Positive Breast CancerMetastatic Hormone Receptor Positive Breast Cancer

Interventions

68Ga-R11228

DRUG

177Lu-R11228

DRUG

Contacts

Kristrun Stardal

CONTACT

8582186617 kstardal@radionetics.com