Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC

  • STATUS
    Recruiting
  • participants needed
    48
  • sponsor
    CytoDyn, Inc.
Updated on 21 January 2022
cancer
serum pregnancy test
measurable disease
breast cancer
anthracyclines
metastasis
neutrophil count
carboplatin
triple negative breast cancer
erbb2
taxane
triple-negative breast cancer
mammogram
excisional biopsy

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

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. 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 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 PFS in patients with CCR5 + mTNBC.

Details
Condition Breast Cancer - HER2 Positive, Triple Negative Breast Cancer, Triple Negative Breast Neoplasms, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, Peripheral Arterial Occlusive Disease, Vaginal Atrophy, Near-Sighted Corrective Surgery, Brain Function, Diet and Nutrition, Skin Wounds, Pediatric Health, Recurrent Respiratory Papillomatosis, Anal Dysplasia, Breast Cancer, Chronic Shoulder Pain, Primary Immunodeficiency, Adverse Effects, Drugs, Injection Port, Chronic Diarrhea
Treatment 350 mg leronlimab, 525 mg leronlimab, 700 mg leronlimab, AUC 5 Carboplatin, Maximum Tolerated Dose (MTD) of leronlimab
Clinical Study IdentifierNCT03838367
SponsorCytoDyn, Inc.
Last Modified on21 January 2022

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