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Triple Negative Breast NeoplasmsPhase 1/2NCT03838367

Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC

A Phase 1/2 study testing 350 mg leronlimab, 525 mg leronlimab and 700 mg leronlimab in people with Triple Negative Breast Neoplasms, run by CytoDyn, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC). Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naïve to chemotherapy in… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Triple Negative Breast Neoplasms
What is being tested?
350 mg leronlimab, 525 mg leronlimab and 700 mg leronlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
22 Apr 2019to 16 Sep 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have a histologically confirmed diagnosis of TNBC. Must demonstrate HER-2 negative (IHC 0, 1+, or fluorescence in situ hybridization (FISH) negative and ER<1%, and PR < 1%, per ASCO/CAP criteria);
  • Demonstrate CCR5 + by IHC (>10% membranous staining completed at the reference laboratory of Dr. Hallgeir Rui at Medical College of Wisconsin).
  • Note: This test will be done as part of the pre-screening period. It will be performed in archival metastatic tissue. If archival tissue is not available then, fresh biopsy will be done;
  • Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion (in case archival tissue is not available);
  • Patients with stage IV de-novo disease or patients that develop recurrence after completion of neoadjuvant or adjuvant therapy are eligible; Note: Patients who have been exposed to carboplatin in neoadjuvant or adjuvant setting will be allowed to enroll, if they have progressed ≥ 6 months from completion of treatment.
  • Phase 1 study section:
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  • Subjects must have disease recurrence and progression after ≤ 2 line of therapy in metastatic setting but untreated with carboplatin;
  • Phase 2 study section:
  • Subjects must be naive to chemotherapy or untreated with carboplatin in metastatic setting (first-line) OR excluding carboplatin chemotherapy, subjects must have failed first-line combination of chemotherapy and a checkpoint inhibitor in metastatic setting;
  • Patients must have measurable disease based on RECIST v1.1;
  • Female patients, ≥ 18 years of age;
  • Patients must exhibit a/an ECOG performance status of 0-1;
  • Life expectancy of at least 6 months;
  • Patients must have adequate organ and bone marrow function within 28 days prior to registration, as defined below:
  • leukocytes ≥ 3,000/mcL;
  • absolute neutrophil count ≥ 1,500/mcL;
  • platelets ≥ 100,000/mcL;
  • total bilirubin: within normal institutional limits;
  • AST(SGOT) \&ALT(SPGT) ≤ 2.5 X institutional upper limit of normal (ULN) (applicable to all patients, irrespective of liver disease or metastasis); and
  • creatinine: within normal institutional limits.
  • Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
  • Females of child-bearing potential (FOCBP) 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 for 60 days after the last dose of study drug (Refer to Appendix 1). Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Note: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; and
  • Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months).
  • FOCBP must have a negative serum pregnancy test at Screening Visit and negative urine pregnancy test prior to receiving the first dose of study drug; and
  • Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.

Who cannot join

  • HER-2 overexpressed/amplified metastatic breast cancer (MBC) (Appendix 2 for guidelines from ASCO);
  • ER and or PR expressing tumors;
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days prior to enrollment;
  • Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible;
  • Patients who have had prior exposure to CCR5 antagonists are not eligible;
  • Patients who have a known additional malignancy that is progressing or requires active treatment are not eligible. Patients who have had a prior diagnosis of cancer and if it has been <3 years since their last treatment are not eligible. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer;
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  • Has an active infection requiring systemic therapy. Note: Patients must complete any treatment with antibiotics prior to registration;
  • Patients who have a known HIV positive status or known/ active Hepatitis B and/or C infection are not eligible;
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Subjects with previously treated 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), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability;
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator;
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial; and
  • Is pregnant or breastfeeding, or expecting to conceive or have children within the projected duration of the trial, starting with the pre-screening or screening visit through the duration of study participation.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • CD07 Investigational Site

    Chicago, Illinois, 60611

  • Quest Clinical Research

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Phase Ib/II Study of Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)

This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC).

Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).

Read the detailed description

Phase Ib

Phase Ib is a dose escalation phase with 3 dose levels (cohorts) of leronlimab (PRO 140) administered in combination with a fixed dose of carboplatin at AUC 5 (area under the curve). This dose finding portion of study will follow a "3+3" designed to determine the maximum tolerated dose (MTD) of leronlimab (PRO 140) administered as subcutaneous (SC) injection in subjects with histologically confirmed mTNBC that express CCR5.

Phase II

Phase II is a single arm study with 30 patients in order to test the hypothesis that the combination of carboplatin AUC 5 intravenously and MTD of leronlimab (PRO 140) SC will increase Progression Free Survival (PFS) in patients with CCR5 + mTNBC.

Being tested
350 mg leronlimab, 525 mg leronlimab, 700 mg leronlimab, AUC 5 Carboplatin, Maximum Tolerated Dose (MTD) of leronlimab
Keywords
TNBC, 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.

  • 350 mg leronlimabDrug

    Also called PRO 140

    leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.

  • 525 mg leronlimabDrug

    Also called PRO 140

    leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.

  • 700 mg leronlimabDrug

    Also called PRO 140

    leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.

  • AUC 5 CarboplatinDrug

    Also called Paraplatin

    Carboplatin is an anticancer drug chemotherapy drug.

  • Maximum Tolerated Dose (MTD) of leronlimabDrug

    Also called PRO 140

    The decision on the MTD will be made following the results obtained from Phase I studies

Study groups in NCT03838367
Study groupRoleWhat they receive
Phase I-Cohort A: 350 mg PRO 140 SC weekly + AUC 5 CarboplatinExperimentalCohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
Receives: Drug: 350 mg leronlimab; Drug: AUC 5 Carboplatin
Phase I-Cohort B: 525 mg PRO 140 SC weekly + AUC 5 CarboplatinExperimentalCohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
Receives: Drug: 525 mg leronlimab; Drug: AUC 5 Carboplatin
Phase I-Cohort C: 700 mg PRO 140 SC weekly + AUC 5 CarboplatinExperimentalCohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
Receives: Drug: 700 mg leronlimab; Drug: AUC 5 Carboplatin
Phase II- MTD to be established for the combination treatmentExperimentalMTD PRO 140 SC + AUC 5 Carboplatin
Receives: Drug: AUC 5 Carboplatin; Drug: Maximum Tolerated Dose (MTD) of leronlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Maximum Tolerated Dose (MTD) of Leronlimab (PRO 140) When Combined With Carboplatin AUC5

    The MTD is defined as 1 dose level (cohort) below the dose in which dose limiting toxicities (DLTs) were observed in >= 33% of the participants.

    Measured: From treatment cycle 1 day 1 (C1D1) until MTD reached (each cycle being 3 weeks), up to 26 weeks

  2. Phase II: Progression Free Survival (PFS) Defined as Time in Months From the Date of First Study Treatment to the Date of Disease Progression or Death From Any Cause, Whichever Comes First.

    All patients who received at least one dose of leronlimab (PRO 140) and carboplatin combination was intended to be included in the primary analyses of PFS. The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria was planned to be used for objective tumor response assessment.

    Measured: Planned every 6 to 9 weeks after Phase II study start, until progression or death, assessing up to 2 years after completion of treatment

Secondary outcomes (7)

  1. Phase I: Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) Collected From the Time of First Treatment Until Study Termination to Evaluate Safety of Leronlimab (PRO 140) and Carboplatin in Subjects With CCR5+ mTNBC.

    For Phase I: Adverse events followed National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This will be the Number of Participants with Any Adverse Events (AE) or Serious Adverse Events (SAE) collected from the time of first treatment until study termination to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ metastatic triple negative breast cancer.

    Measured: From Cycle 1, Day 1 (each treatment cycle is 3 weeks) until last dose of study drug, up to 26 weeks

  2. Phase II: Progression Free Survival (PFS) According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)

    Phase II: Progression Free Survival (PFS) according to RECIST v1.1 in participants with Detectable Programmed Death-Ligand 1 (PD-L1)

    Trial was terminated prematurely and no efficacy data was collected from the Phase II portion.

    Measured: Planned every 6 to 9 weeks after Phase II study start, until progression or death, assessing up to 2 years after completion of treatment

  3. Phase II: Overall Response Rate (ORR, Defined as Complete Response (CR) + Partial Response (PR)), and Clinical Benefit Rate (CBR, Defined as CR + PR + Stable Disease (SD)) in Subjects With CCR5+ mTNBC Treated With Leronlimab (PRO 140) and Carboplatin.

    Phase II: Overall response rate (ORR, defined as Complete Response (CR) + Partial Response (PR)), and clinical benefit rate (CBR, defined as CR + PR + Stable Disease (SD)) in subjects with CCR5+ mTNBC treated with

    The trial was terminated early, efficacy data is not available

    Measured: Planned every 6 to 9 weeks after Phase II study start, until progression or death, assessing up to 2 years after completion of treatment

  4. Phase II: Time to New Metastases (TTNM)

    Trial was terminated prematurely and no efficacy data was collected.

    Measured: Planned every 6 to 9 weeks after Phase II study start, until progression or death, assessing up to 2 years after completion of treatment

  5. Phase II: The Change From Baseline in Circulating Tumor Cells (CTC) Level in the Peripheral Blood.

    Phase II: The change from baseline in circulating tumor cells (CTC) level in the peripheral blood.

    No efficacy data was available due to early termination of the trial.

    Measured: Planned every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.

  6. Phase II: Overall Survival Defined as Time in Months From the Date of First Study Treatment to the Date of Death;

    Phase II: Overall survival defined as time in months from the date of first study treatment to the date of death; No efficacy data is available due to early termination of the trial.

    Measured: Planned from Day 1 to death from any cause, assessing up to 2 years after completion of treatment.

  7. Phase II: Number, Frequency, and Severity of AEs Collected From the Time of First Treatment Until 12 Weeks After Study Treatment Completion to Evaluate Safety of Leronlimab (PRO 140) and Carboplatin in Subjects With CCR5+ mTNBC.

    Phase II: Number, frequency, and severity of AEs collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC.

    No safety data was available from the Phase II portion of the trial due to early termination of the study.

    Measured: Planned from Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2019
  2. Study start22 Apr 2019
  3. Primary completion15 Jul 2022
  4. Study completion16 Sep 2022

Why it stopped: Study terminated prematurely due to business reasons. Participants are no longer examined or receiving intervention.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03838367
Sponsor's protocol ID
CD07_TNBC
Status last verified
Aug 2025
First submitted
5 Feb 2019
Last updated
9 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 350 mg leronlimab, 525 mg leronlimab and 700 mg leronlimab in people with Triple Negative Breast Neoplasms, run by CytoDyn, Inc. at 2 sites 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 26 inclusion and 12 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: stopped early, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Phase I: Maximum Tolerated Dose (MTD) of Leronlimab (PRO 140) When Combined With Carboplatin AUC5 (time frame: From treatment cycle 1 day 1 (C1D1) until MTD reached (each cycle being 3 weeks), up to 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03838367.

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 9 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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