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

NCT03838367 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-09

Study results available
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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 metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).

Conditions

  • Triple Negative Breast Neoplasms

Interventions

DRUG

350 mg leronlimab

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

DRUG

525 mg leronlimab

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

DRUG

700 mg leronlimab

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

DRUG

AUC 5 Carboplatin

Carboplatin is an anticancer drug chemotherapy drug.

DRUG

Maximum Tolerated Dose (MTD) of leronlimab

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

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • CytoDyn, Inc.

    lead INDUSTRY

Principal Investigators

  • Jacob Lalezari, MD · CytoDyn, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2022-07-15
Completion
2022-09-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03838367 on ClinicalTrials.gov