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A Compassionate Use Study of Leronlimab in Breast Cancer

Metastatic Triple-Negative Breast Carcinoma Clinical Trial

Official title:
A Compassionate Use Study of Leronlimab (PRO 140) in Combination With Treatment of Physician's Choice in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)

Clinical Trial Summary

This is a single arm, compassionate use study with 30 patients for leronlimab (PRO 140) combined with a treatment of physician's choice (TPC) in patients with CCR5+ mTNBC.

Clinical Trial Description

This is a single arm, compassionate use study with 30 patients for leronlimab (PRO 140) combined with a treatment of physician's choice (TPC) in patients with CCR5+ mTNBC. Leronlimab (PRO 140) will be administered subcutaneously as weekly dose of 350 mg until disease progression or intolerable toxicity. Treatment of Physician's Choice (TPC) is defined as one of the following single-agent chemotherapy drugs administrated according to local practice: eribulin, gemcitabine, capecitabine, paclitaxel, nab-paclitaxel, vinorelbine, ixabepilone, or carboplatin. The selected treatment should be administered as per the dosing schedule included on the package insert. In this study, patients will be evaluated for tumor response approximately every 3 months or according to institution's standard practice by CT, PET/CT or MRI with contrast (per treating investigator's discretion) using the same method as at baseline. Tumor measurements will be done using RECIST v1.1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04313075
Study type Expanded Access
Source CytoDyn, Inc.
Contact
Status No longer available
Phase
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See also
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