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RECRUITING
NCT07311993
PHASE1

Phase 1 Study of CLR 125 in Triple Negative Breast Cancer

Sponsor: Cellectar Biosciences, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 1b, Open-Label Parallel Study Evaluating CLR 125 in Patients With Relapsed or Refractory Triple Negative Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-12-05

Completion Date

2029-07

Last Updated

2026-01-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

Iopofosine I 131

Investigational radiopharmaceutical product intended for IV administration.

DRUG

CLR 125

Investigational radiopharmaceutical product intended for IV administration.

Locations (2)

Mayo Clinic Florida

Jacksonville, Florida, United States

United Theranostics

Glen Burnie, Maryland, United States