- This study is researching the effectiveness and safety of different doses and dosing regimens of CLR 125 as a potential treatment for TNBC. Researchers will also evaluate any potential responses and side effects.
- The goal of the CLR 125 TNBC study is to identify participant’s tumors and determine the most effective and safest dose of CLR 125 for future trials.
- CLR 125 is an investigational study therapy. An investigational study therapy is one that has not been approved by the US Food and Drug Administration (FDA) or any other regulatory agency.
What is the purpose of the CLR 125 TNBC Study?
Who can participate in the CLR 125 TNBC Study?
To qualify for this study, participants must meet the following requirements:
Note: other criteria apply.
- Be 18 years of age or older
- Have confirmed diagnosis of triple negative (ER-, PR-, HER2-) breast cancer
- Have received previous treatment for TNBC
Note: other criteria apply.
What will happen during the study?
Qualifying participants who decide to join the study will participate in the imaging phase (2 weeks duration) and can choose to join the study therapeutic phase (4 to 8 months duration). All participants will also complete a screening period.
1. Screening (up to 14 days) – Receive study tests to confirm qualification for the study ; will include blood tests. 2. Imaging Phase (about 2 weeks) - Imaging phase (dosimetry) to help map the tumor, personalize treatment and better understand how the drug behaves in the body. Participants will receive a small “tracer” dose to allow the detection of any tumors (both primary and metastatic) and to see how the drug is taken up by tumors and in various organs and the whole body. After the tracer dose, you will undergo 4 specialized scans and have 6 blood collections over an 11-day period. The specialized scans are paid for by the study; compensation for time and travel may be available. After this imaging phase is finished, participants can decide whether to receive CLR 125 treatment in the trial or stay on their current treatment plan. Taking part in the imaging phase does not require participants to change existing care or lock them into participating in the dosing phase.
1. Screening (up to 14 days) – Receive study tests to confirm qualification for the study ; will include blood tests. 2. Imaging Phase (about 2 weeks) - Imaging phase (dosimetry) to help map the tumor, personalize treatment and better understand how the drug behaves in the body. Participants will receive a small “tracer” dose to allow the detection of any tumors (both primary and metastatic) and to see how the drug is taken up by tumors and in various organs and the whole body. After the tracer dose, you will undergo 4 specialized scans and have 6 blood collections over an 11-day period. The specialized scans are paid for by the study; compensation for time and travel may be available. After this imaging phase is finished, participants can decide whether to receive CLR 125 treatment in the trial or stay on their current treatment plan. Taking part in the imaging phase does not require participants to change existing care or lock them into participating in the dosing phase.
- 3. Dosing phase with administration of CLR 125 (about 4 to 8 months) - You will be randomly assigned to 1 of 3 groups: • CLR 125 4 times per 8-week cycle, for up to ~8 months • CLR 125 4 times per 8-week cycle, for up to ~6 months • CLR 125 4 times per 8-week cycle, for up to ~4 months
- During this phase, participants will visit the study clinic to receive infusions of CLR 125. The study team will perform tests and assessments to check your health throughout all cycles and for about 57 days post the last dose. Your health will be monitored throughout all cycles and actively for the first year from initial dosing.
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- Compensation for travel may be available.
- 4. Follow-up (~1 year) – Participants in the dosing phase will complete study clinic visits at least 4 times after the last cycle of the study therapy. This will give the study team more information about their health and how CLR 125 works. Some of these visits may be completed by phone.
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- The total time for participation in both phases (imaging and dosing) of the study may be up to 2 years.
- Note: CLR 125 is an investigational study therapy. An investigational study therapy is one that has not been approved by the US Food and Drug Administration (FDA) or any other regulatory agency.
Where is the study available?
The study is currently enrolling participants at:
United Theranostics: Glen Burnie, Maryland
United Theranostics: Princeton, New Jersey
Mayo Clinic, Jacksonville, Florida
Mayo Clinic, Rochester, Minnesota Rochester, MN 55905
Interested? Contact us
- Crain Health Park 331 Oak Manor Drive Suite 201 Glen Burnie, MD 21061
United Theranostics: Princeton, New Jersey
- Forrestal Medical Building 8 Forrestal Road South Suite 201 Princeton, NJ 08540
Mayo Clinic, Jacksonville, Florida
- 4500 San Pablo Rd S
Mayo Clinic, Rochester, Minnesota
- 200 1st St SW
- Low receptor expression is acceptable
- Participants with metastatic disease may be eligible for participation