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Phase 1 Study of CLR 125 in Triple Negative Breast Cancer

NCT07311993 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Iopofosine I 131

Investigational radiopharmaceutical product intended for IV administration.

DRUG

CLR 125

Investigational radiopharmaceutical product intended for IV administration.

Sponsors & Collaborators

  • Cellectar Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Jarrod Longcor · Cellectar Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2028-02-29
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311993 on ClinicalTrials.gov