RecruitingPhase 1NCT07311993

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

Sponsor

Cellectar Biosciences, Inc.

Enrollment

60 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 trial tests a new drug called CLR 125 — a targeted radiation therapy — in people with triple-negative breast cancer (TNBC), a type that lacks three specific receptors and is particularly hard to treat. The study focuses on safety and finding the right dose. **You may be eligible if...** - You have confirmed triple-negative breast cancer (hormone receptor-negative and HER2-negative) - Your cancer has continued to grow or spread after at least one prior standard treatment - You are 18 or older - Your overall health is adequate (ECOG performance status acceptable) - If you received chemotherapy before or after surgery, at least one year has passed since that treatment **You may NOT be eligible if...** - Your breast cancer is not triple-negative - You have not yet tried any standard therapies - You have significant organ problems or other conditions preventing participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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