CLR 125 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, CLR 125, for patients with advanced triple negative breast cancer. The goal is to determine the best dose and understand any side effects. Participants will receive the treatment through infusions and visit the clinic for checkups. Some will also receive another drug, CLR 131 (also known as Iopofosine I 131), to assess how the treatment affects the body and tumor. This trial may suit those who have tried other treatments but still need options for managing their triple negative breast cancer. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot have had antitumor systemic therapy or investigational therapy within a certain period before starting the study drug. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that CLR 125 remains in the early testing phase for advanced triple negative breast cancer. This first stage of clinical trials focuses on safety and determining the correct dose. Consequently, limited safety information is available. However, the trial's existence suggests that earlier, smaller studies did not reveal major safety issues.
In related research, a similar treatment called CLR 131 has been tested in other cancer types. It showed promising results, working well in patients who could receive more radiation treatment. This may offer some insight into the safety of CLR 125, as both treatments share similarities.
Participants must report any side effects to help researchers understand how well CLR 125 is tolerated. Those considering joining this study should know that the main goal is to ensure the treatment's safety for humans. Participants receive close monitoring with regular checkups and tests to ensure safety.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for breast cancer, which often include surgery, chemotherapy, and hormone therapy, CLR 125 offers a unique approach by utilizing a targeted radiopharmaceutical method. CLR 125 uses Iopofosine I 131, a radioactive compound, to deliver radiation directly to cancer cells, potentially minimizing damage to healthy cells. This precise targeting could lead to fewer side effects and improved outcomes. Researchers are excited because this treatment may offer a new way to control or reduce tumor growth more effectively than existing options.
What evidence suggests that CLR 125 could be an effective treatment for advanced triple negative breast cancer?
Research has shown that CLR 125, a new treatment under study in this trial, could benefit advanced triple-negative breast cancer. In lab studies, it significantly shrank tumors. CLR 125 delivers a type of radiation directly to cancer cells, potentially stopping their growth. Early studies suggest it could effectively treat these challenging cancers. Although more research is necessary, these initial results are promising for its potential use. Participants in this trial will receive CLR 125 in varying dosages across separate treatment arms to evaluate its effectiveness and safety.15678
Who Is on the Research Team?
Jarrod Longcor
Principal Investigator
Cellectar Biosciences
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced triple negative breast cancer who've had at least one prior treatment fail. They need a certain level of blood cells and hemoglobin, be at least a year out from any neo-adjuvant or adjuvant therapy, have an ECOG performance status of 0 to 2, and a life expectancy of more than six months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dosimetry Phase
Iopofosine I 131 (CLR 131) is administered for imaging purposes to assess total body, organ, and tumor dosimetry
Treatment Phase
CLR 125 is administered via infusion 4 times each cycle, repeated every 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CLR 125
- Iopofosine I 131
Trial Overview
The study tests three dose levels of CLR 125 given via infusion every two weeks in cycles repeated every eight weeks. It aims to determine the best dose for future trials and monitor side effects. Some may also receive CLR 131 to assess radiation delivery to organs and tumors.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
CLR 125 will be administered at 190 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 2 cycles.
CLR 125 will be administered at 125 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 3 cycles.
CLR 125 administered at 65 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 4 cycles.
Iopofosine I 131 (CLR 131) will be administered at 10 mCi on day 1 for approximately 15 patients for imaging purposes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cellectar Biosciences, Inc.
Lead Sponsor
Citations
Phase 1 Parallel Study of CLR 125 in Triple Negative ...
The goal of this clinical trial is to evaluate the safety and efficacy of 3 different dose levels of CLR 125 in patients with advanced ...
Cellectar Biosciences Submits Phase 1b Clinical Trial ...
CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers. “ ...
3.
onclive.com
onclive.com/view/iopofosine-i-131-generates-early-efficacy-signals-in-waldenstr-m-macroglobulinemiaIopofosine I 131 Generates Efficacy Signals in ...
Furthermore, the stringent complete remission rate was 8%. These disease outcomes with iopofosine I 131 exceed those in real-world studies in ...
Phase 1 Parallel Study of CLR 125 in Triple Negative ...
To determine the therapeutic activity defined as Progression Free Survival (PFS) using Kaplan Meier estimator. Assessed throughout the study through 1 year ...
CLR 125 Auger Electrons for the Targeted Radiotherapy of ...
Targeted radionuclide therapy with CLR 125 displayed significant antitumor efficacy in vivo, suggesting promise for treatment of TNBC micrometastases.
News & Events
Enroll patients in the Phase 1b study of CLR 125 in TNBC with interim data expected in mid-2026; Present final findings and subset analysis ...
Articles Safety and toxicity of Iopofosine I 131 (CLR ...
This study showed meaningful activity of CLR 131 in patients with recurrent head and neck cancers who are able to undergo re-irradiation therapy.
8.
onclive.com
onclive.com/view/iopofosine-i-131-meets-mrr-end-point-in-r-r-waldenstr-m-macroglobulinemiaIopofosine I 131 Meets MRR End Point in R/R ...
The 18-month progression-free survival rates were 78% for patients experiencing a major response and 72% for those achieving an overall response ...
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