Access to Leronlimab for Patients with Advanced Triple-Negative Breast Cancer
Sponsor: CytoDyn, Inc.
Expanded Access
Sponsor score: 40
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
| Parameter | Options |
|---|
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Oregon Oncology Specialists | 97301 | Salem | Oregon |
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