Phase 1 Study of CLR 125 in Triple Negative Breast Cancer
A Phase 1b, Open-Label Parallel Study Evaluating CLR 125 in Patients With Relapsed or Refractory Triple Negative Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 weeks
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "These participants will: * Have 4 scans completed over 2 weeks * Have blood drawn 6 times over 2 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests three doses of CLR 125 in adults with advanced triple negative breast cancer that has gotten worse after treatment. It looks at safety, side effects, and how well the drug works to help choose a dose and treatment schedule for future studies. CLR 125 is given through a vein four times per cycle, with cycles repeated every 8 weeks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older with confirmed triple negative breast cancer: ER and PR test results below 10% each, and a negative HER2 test.
- Have cancer that got worse after at least one standard drug treatment. If you had treatment before or after surgery, at least one year must have passed since that treatment.
- Be able to care for yourself and be up and about for at least half of your waking hours. Be expected to live at least 6 months.
- Meet the study’s blood count, kidney, and liver test limits.
- Have at least one tumor that can be measured: at least 10 mm across, or a lymph node at least 15 mm across its shorter side.
- If cancer has spread to the brain, finish treatment for it and have no new signs or symptoms for at least 1 month. Steroid doses must be unchanged for 3 weeks or being lowered.
- Be willing and able to follow study visits, tests, and treatment. You or your legal representative must understand the study and sign a consent form.
- If you can become pregnant, have a negative pregnancy test within 24 hours before dosing and use highly effective birth control during the study and for 12 months after the study drug. Men who can father a child must use condoms for the same period.
Who can't join
- Have had cancer drugs or experimental treatment too recently; the wait depends on how long the drug stays in your body. Radiation to areas not being measured must end at least 2 weeks before dosing. Study-related CLR 131 needs no waiting period before CLR 125.
- Have had targeted radiation treatment, or outside-the-body radiation that exposed more than 20% of your bone marrow to more than 20 Gy, a measure of radiation dose.
- Still have moderate or worse side effects from past treatment that the study doctor thinks could worsen, except hair loss.
- Have had or currently have another cancer. Exceptions are certain skin cancers, very early melanoma or cervical cancer, and successfully treated prostate cancer; these must be fully treated with no signs of disease for at least 2 years.
- Have another serious illness or organ problem that the study doctor thinks could make treatment unsafe or affect the safety results.
- Have a known history of HIV or an uncontrolled, serious, active infection.
- Be pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 deruxtecan). * 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 for at least 1 month, and on a stable dose of steroids (unchanged for three weeks prior to registration or on a steroid tapering regimen). * 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 include combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, vasectomized partner, or sexual abstinence. Women who have undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation, or are post-menopausal (no menses for 12 months without an alternative medical cause) are considered to be of non-childbearing potential. * 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. Exclusion Criteria: * Antitumor systemic therapy or investigational therapy, within three-half-lives of the agent preceding study drug administration. NOTE: Patients participating in non-interventional clinical trials (i.e., non-drug) are allowed to participate in this trial. * 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 treatment or surgical excision; melanoma in situ; treated cervical carcinoma in situ; successfully treated prostate cancer. * 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 evaluation of the safety of the test drug. * Known history of human immunodeficiency virus or uncontrolled, serious, active infection. * Pregnancy or breast-feeding
Study sites (4)
FL
- Mayo Clinic Florida · Jacksonville, FL 32224Clinical Trials Referral Office · Study contact · 855-776-0015 · CancerTrials@mayo.eduPooja Advani, MD · Principal investigatorMore trials in Jacksonville
MD
- United Theranostics · Glen Burnie, MD 21061Amanda Huggins · Study contact · 667-467-3669 · clinicaltrial@unithera.comBabak Saboury, MD · Principal investigatorMore trials in Glen Burnie
MN
- Mayo Clinic Rochester · Rochester, MN 55905Clinical Trials Referral Office · Study contact · 855-776-0015 · CancerTrials@mayo.eduKarthik Giridhar, MD · Principal investigatorMore trials in Rochester
NJ
- United Theranostics · Princeton, NJ 08540Amanda Huggins · Study contact · 667-467-3669 · clinicaltrial@unithera.comMunir Ghesani, MD · Principal investigatorMore trials in Princeton