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

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing a new targeted imaging and treatment agent for hormone receptor-positive (HR+), HER2-negative breast cancer that has spread (metastatic). The drug uses two different radioisotopes: 68Ga-R11228 for PET scanning to detect cancer, and 177Lu-R11228 for delivering targeted radiation therapy directly to cancer cells. **You may be eligible if...** - You are 18 or older (male or non-pregnant female) with confirmed HR+/HER2- breast cancer that has returned locally or spread to other parts of the body - For the imaging part (Part A): you have at least one measurable lesion - For the treatment part (Part B): your cancer has stopped responding to standard hormone therapy and CDK4/6 inhibitors, and you have received prior chemotherapy for metastatic disease **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have significant organ dysfunction (heart, liver, kidneys) - Your cancer is HER2-positive - You have active brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07121244


Related Trials