TNBCNCT07536815
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)
A study testing leronlimab (PRO 140) in people with TNBC and TNBC - Triple-Negative Breast Cancer, run by CytoDyn, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TNBC, TNBC - Triple-Negative Breast Cancer, TNBC, Triple Negative Breast Cancer
- What is being tested?
- leronlimab (PRO 140)
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- leronlimab (PRO 140)
- Keywords
- leronlimab, PRO 140
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leronlimab (PRO 140)Drug
Also called leronlimab, PRO 140
Leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- CytoDyn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WEP Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536815
- Sponsor's protocol ID
- CD-O-202
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07536815
- Acronym / sponsor ID
- CD-O-202
- Keywords
- leronlimab, PRO 140
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- CytoDyn, Inc.Industry (pharma, biotech, devices)
- Collaborators
- WEP Clinical
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leronlimab (PRO 140)Also: leronlimab, PRO 140Leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Related trials for TNBC
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate YF550 in Participants With Locally Advanced or Metastatic Solid Tumors.
Solid Tumor (Phase I), Ovarian Cancer
RecruitingPhase 1
A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
Triple Negative Breast Cancer
RecruitingPhase 2
Reverse Triple Negative Immune Resistant Breast Cancer
Triple-negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leronlimab (PRO 140) in people with TNBC and TNBC - Triple-Negative Breast Cancer, run by CytoDyn, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.