drugset / Trial / NCT07311993

Phase 1 Study of CLR 125 in Triple Negative Breast Cancer

NCT07311993 ↗

Phase 1 Recruiting 60 enrolled Cellectar Biosciences, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-12-05
Primary completion
2028-02
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Subject CLR 125 Unknown 2405 mbq Intravenous
Subject CLR 125 Unknown 4625 mbq Intravenous
Subject CLR 125 Unknown 7030 mbq Intravenous
Subject I-131-CLR1404 Small molecule 370 mbq Intravenous

Indications