Access to Leronlimab for Patients with Advanced Triple-Negative Breast Cancer

Sponsor: CytoDyn, Inc.

Expanded Access
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07536815

This program offers access to the investigational drug leronlimab for patients with advanced or metastatic triple-negative breast cancer who have no other satisfactory treatment options and cannot join a clinical trial.

Patient Parameters

Program Overview

This program allows patients with advanced or metastatic triple-negative breast cancer (TNBC) to access leronlimab, an investigational drug, if they have no other effective treatment options and cannot participate in a clinical trial. Leronlimab is being studied for its potential to help patients with this type of cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults over 18 years old.
  • Diagnosed with advanced or metastatic triple-negative breast cancer (TNBC) that has progressed after standard treatments.
  • Unable to receive standard treatments due to side effects or lack of options.
  • Willing to provide a new tumor sample if an old one is not available.
  • Cannot join any current clinical trials for leronlimab.
  • Have good organ and bone marrow function as determined by the doctor.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Agree to use two forms of birth control or abstain from sex during the study and for 4 months after the last dose.
  • Willing to follow study requirements and attend follow-up visits.
  • Able to understand and sign a consent form before joining the study.

Exclusion Criteria

  • History of allergic reactions to similar drugs as leronlimab.
  • Have active cancer spread to the brain or spinal fluid, unless previously treated and stable.
  • Have uncontrolled illnesses like infections or heart failure that could interfere with treatment.
  • Currently participating in another clinical trial.
  • Pregnant or breastfeeding.
  • Any condition that could interfere with safe treatment.
  • Have psychiatric or substance abuse issues that could affect participation.

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