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New treatment option for Breast Cancer
Official title Phase 1 Study of CLR 125 in Triple Negative Breast Cancer
ClinicalTrials.gov ID: NCT07311993
What this study is testing
What is Iopofosine I 131?
Iopofosine I 131 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as CLR 131.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Unequivocal TNBC histology [ER and PR less than 10% each and HER-2 negative].
- Patients that have progressed after at least one prior standard therapeutic regimen given alone or in combination (including, but not limited, to...
- Patients who have received neo-adjuvant or adjuvant therapy must be at least one year from that treatment regimen.
- Patient is ≥ 18 years of age.
- ECOG performance status of 0 to 2.
You likely can't join if
- Antitumor systemic therapy or investigational therapy, within three-half-lives of the agent preceding study drug administration. NOTE: Patients...
- Focal radiation (including palliative radiation) to non-target lesions should be completed at least 2 weeks prior to dosing.
- For patients receiving CLR 125 after participation in the dosimetry phase, CLR 131 washout is not required prior to dosing with CLR 125.
- Prior targeted radiotherapy.
- Prior external beam radiation therapy resulting in greater than 20% of total bone marrow receiving greater than 20 Gy. For estimation purposes, the...
- Vertebral bodies: Cervical 0.5%, thoracic 1%, lumbar 2% per vertebral body
See the full eligibility criteria
- Unequivocal TNBC histology [ER and PR less than 10% each and HER-2 negative].
- Patients that have progressed after at least one prior standard therapeutic regimen given alone or in combination (including, but not limited, to: chemotherapy, immunotherapy, sacituzumab govitecan-hziy, trastuzumab...
- Patients who have received neo-adjuvant or adjuvant therapy must be at least one year from that treatment regimen.
- Patient is ≥ 18 years of age.
- ECOG performance status of 0 to 2.
- Life expectancy ≥ 6 months.
- Patient must meet the following laboratory criteria:
- Platelets ≥ 75,000/uL [75 x 10\^9/L]
- White blood cell (WBC) count ≥ 3000/uL
- Absolute neutrophil count ≥ 1500/uL
- Hemoglobin ≥ 9 g/dL
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 (as reported by the local lab)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN)
- Bilirubin \< 1.5 × ULN
- At least one measurable lesion, as defined by RECIST v1.1, with longest diameter at baseline ≥ 10 mm (excluding lymph nodes, for which the short diameter must be ≥ 15 mm).
- Patients with known brain metastases must have completed any radiotherapy or systemic treatments for brain metastases prior to enrollment; by investigator assessment be considered stable with no new signs or symptoms...
- Patients must express willingness and ability to comply with scheduled study visits, treatment plans, laboratory tests, and other study procedures.
- Patient or their legally authorized representative must have the ability to understand and provide signed informed written consent before the initiation of any study-related procedures.
- Female patients of childbearing potential must have a negative pregnancy test within 24 hours of dosing.
- Women of childbearing potential must agree to use a highly effective method of contraception during the study and for 12 months following administration of the study drug. Highly effective methods of contraception...
- Men who are able to father a child must agree to use a condom during the study and for 12 months following administration of the study drug.
- Antitumor systemic therapy or investigational therapy, within three-half-lives of the agent preceding study drug administration. NOTE: Patients participating in non-treatment clinical trials (i.e., non-drug) are allowed...
- Focal radiation (including palliative radiation) to non-target lesions should be completed at least 2 weeks prior to dosing.
- For patients receiving CLR 125 after participation in the dosimetry phase, CLR 131 washout is not required prior to dosing with CLR 125.
- Prior targeted radiotherapy.
- Prior external beam radiation therapy resulting in greater than 20% of total bone marrow receiving greater than 20 Gy. For estimation purposes, the following bone marrow percentages can be used:
- Vertebral bodies: Cervical 0.5%, thoracic 1%, lumbar 2% per vertebral body
- Hemipelvis (ilium, acetabulum, ischium): 13% per side
- Sacrum: 10%
- Skull: 12%
- Scapula: 5% per side
- Ribs: 4% per side
- Femur: 3% per side
- Ongoing Grade 2 or greater toxicities due to previous therapies, excluding alopecia, that in the opinion of investigator might be exacerbated by study treatment.
- Patients with prior or concurrent malignancy other than TNBC with the following exceptions, which must be fully treated with no evidence of disease for at least 2 years: non-melanoma skin cancers only requiring topical...
- Any other concomitant serious illness or organ system dysfunction (including cardiac and pulmonary dysfunction) that in the opinion of the Investigator would either compromise patient safety or interfere with the...
- Known history of human immunodeficiency virus or uncontrolled, serious, active infection.
- Pregnancy or breast-feeding
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Glen Burnie, Maryland, United States
- Rochester, Minnesota, United States
- Princeton, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Glen Burnie, Maryland, United States; Rochester, Minnesota, United States; Princeton, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.