Actively Recruiting
Phase 1 Study of CLR 125 in Triple Negative Breast Cancer
Led by Cellectar Biosciences, Inc. · Updated on 2026-04-14
60
Participants Needed
3
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 triple negative breast cancer. The main questions the study aims to answer are: * What dose and regimen should be used in future trials of CLR 125 in patients with advanced triple negative breast cancer. * What side effects do participants have when taking CLR 125. Participants will: * Have CLR 125 administered via infusion 4 times each cycle; repeated every 8 weeks. * Visit the clinic once every 3 weeks for checkups and testing. * Report any side effects or new medications. Some participants may also receive one dose of CLR 131 to evaluate the amount of radiation delivered to various organs and to the tumor. These participants will: * Have 4 scans completed over 2 weeks * Have blood drawn 6 times over 2 weeks.
CONDITIONS
Official Title
Phase 1 Study of CLR 125 in Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of triple negative breast cancer with ER and PR less than 10% and HER-2 negative
- Disease progression after at least one prior standard treatment regimen, including chemotherapy or immunotherapy
- At least one year since any neo-adjuvant or adjuvant therapy
- Age 18 years or older
- ECOG performance status between 0 and 2
- Life expectancy of at least 6 months
- Adequate blood counts: platelets 75,000/uL or higher, white blood cells 3000/uL or higher, absolute neutrophil count 1500/uL or higher, hemoglobin 9 g/dL or higher
- Adequate kidney function with estimated glomerular filtration rate 30 mL/min/1.73 m2 or higher
- Liver enzymes AST and ALT less than or equal to 2.5 times the upper limit of normal
- Bilirubin less than 1.5 times the upper limit of normal
- At least one measurable tumor lesion 10 mm or larger (15 mm for lymph nodes)
- Stable brain metastases if present, with no new symptoms for at least 1 month and stable steroid use
- Willingness and ability to follow study visits, treatments, and tests
- Ability to understand and provide informed consent
- Negative pregnancy test within 24 hours of dosing for women of childbearing potential
- Use of highly effective contraception during the study and for 12 months after treatment for women of childbearing potential
- Agreement to use condoms during the study and for 12 months after treatment for men able to father children
You will not qualify if you...
- Use of antitumor or investigational therapies within three half-lives before study drug administration
- Focal radiation to non-target lesions within 2 weeks before dosing
- Prior targeted radiotherapy
- Prior external beam radiation resulting in more than 20% of bone marrow receiving over 20 Gy
- Ongoing Grade 2 or higher toxicities from previous treatments, except hair loss, that might worsen with study treatment
- History of other cancers except certain treated cancers with no disease for at least 2 years
- Serious illnesses or organ dysfunctions that could affect safety or study evaluation
- Known HIV infection or uncontrolled serious infections
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
2
United Theranostics
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
3
United Theranostics
Princeton, New Jersey, United States, 08540
Actively Recruiting
Research Team
K
Kate Oliver
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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