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Phase 1 Study of CLR 125 in Triple Negative Breast Cancer

StatusRecruiting
PhasePhase 1
Started2025-12-05
View on ClinicalTrials.gov ↗

Amendment history

2026-06-01
Study Status, Contacts/Locations v4
Study sites3→4
2026-05-21
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 3 sites
2026-04-13
Study Status, Contacts/Locations v2
Study sites2→3
2026-01-08
Study Identification, Study Status v1
Study title-9 characters
Phase 1 Parallel Study of CLR 125 in Triple Negative Breast Cancer
2025-12-16
Original filing
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.
Trial Details
NCT Number NCT07311993
Lead Sponsor Cellectar Biosciences, Inc.
Conditions Breast Cancer
Enrollment 60 participants
Start Date 2025-12-05
Primary Completion 2028-02 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-03