NCT07121244

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Radionetics Oncology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locoregionally Recurrent Hormone-receptor Positive Breast Cancer
• Metastatic Hormone Receptor Positive Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-06-01
• Completion: 2033-06-01
• First posted: 2025-08-13
• Last updated: 2026-04-13

Locations

7 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study