An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC)

April 23, 2026 updated by: CytoDyn, Inc.
This Expanded Access Program provides investigational access to leronlimab (PRO 140) for patients with advanced or metastatic triple-negative breast cancer (TNBC) who lack satisfactory treatment options and are unable to participate in a clinical trial.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Salem, Oregon, United States, 97301
        • Available
        • Oregon Oncology Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Adult participants > 18 years of age.
  • Histologically confirmed HR-/HER2- metastatic TNBC using ASCO/CAP criteria, Stage IIIB-IV.
  • Must have experienced disease progression on prior standard of care (SoC) therapy, be ineligible for SoC due to intolerance or contraindications, or have no remaining SoC treatment options available.
  • Be willing to provide tissue from a newly obtained core or excisional biopsy of an accessible tumor lesion if archival tissue is not available.
  • Must not be eligible for or able to enroll in any trials investigating leronlimab that are currently recruiting.
  • Participant must have adequate organ and bone marrow function within 14 days prior to enrollment as determined by the investigator.
  • ECOG performance status 0-2.
  • Participants of childbearing potential (POCBP) and males must agree to use two medically accepted methods of contraception with hormonal or barrier method of birth control, or abstinence, prior to study entry, for the duration of study participation and 4 months after the last dose of study drug.
  • Willingness and ability to comply with protocol requirements and attend follow-up visits.
  • Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.

Exclusion Criteria:

  • Participants who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible.
  • Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Subjects with previously treated/stable brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline) and have no evidence of new or enlarging brain metastases. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Any uncontrolled concurrent illness (e.g., infection, heart failure) that, in the investigator's judgment, would interfere with the patient's ability to safely receive treatment. Note: Patients must complete any treatment with antibiotics prior to registration.
  • Concurrent participation in another interventional clinical trial.
  • Pregnant or breastfeeding women.
  • Any condition that, in the investigator's judgment, would interfere with the patient's ability to safely receive treatment.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytoDyn, Inc.

Collaborators

WEP Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-O-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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