NCT03838367

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: CytoDyn, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-22
• Primary completion: 2022-07-15
• Completion: 2022-09-16
• First posted: 2019-02-12
• Last updated: 2025-09-09
• Results posted: 2025-09-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study