Actively Recruiting
A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer
Led by Radionetics Oncology · Updated on 2026-04-13
62
Participants Needed
7
Research Sites
400 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.
CONDITIONS
Official Title
A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older
- For Part B: refractory to endocrine therapy with no limit on prior treatments including CDK4/6, AKT, PI3K, or mTOR inhibitors
- For Part B: received or declined at least one line of chemotherapy or antibody drug conjugate in the locoregionally recurrent or metastatic setting
- For Part B: progressive disease or intolerance to last treatment
- For Part B: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- For Part B: life expectancy of at least six months
- For Part B: adequate bone marrow reserve, hepatic function, and renal function
You will not qualify if you...
- Not recovered from clinically significant adverse events from the most recent anticancer therapy or intervention
- Known central nervous system disease, except stable treated brain metastasis for at least 1 month without progression or hemorrhage and no ongoing corticosteroid use
- Radiotherapy for breast cancer within 28 days prior to study
- Received radionuclide treatment within less than 10 physical half-lives before dosing with 68Ga-R11228
- Any condition that prevents proper performance of required imaging procedures
- For Part B: treatment with anticancer therapy or investigational drug/device within 21 days or 5 half-lives (whichever is shorter)
- For Part B: prior systemic radionuclide therapeutic treatment
- For Part B: unresolved Grade 2 or higher toxicity (except alopecia and Grade 2 platinum-therapy neuropathy) from prior breast cancer treatments or medical/surgical procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
United Theranostics
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
3
United Theranostics Princeton
Princeton, New Jersey, United States, 08540
Actively Recruiting
4
University Hospital Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
6
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
7
Melbourne Theranostic Innovation Centre (MTIC)
Melbourne, Australia
Actively Recruiting
Research Team
K
Kristrun Stardal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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