Phase 1 Study of CLR 125 in Triple Negative Breast Cancer (NCT07311993)
A Phase 1b, Open-Label Parallel Study Evaluating CLR 125 in Patients With Relapsed or Refractory Triple Negative Breast Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Florida — Jacksonville, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Mayo Clinic Florida — Jacksonville, Florida
- United Theranostics — Glen Burnie, Maryland
- Mayo Clinic Rochester — Rochester, Minnesota
- United Theranostics — Princeton, New Jersey
📞 Contact the Study Coordinator
Phone: (608) 441-8120
Email: clinical@cellectar.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.