A Compassionate Use Study of Leronlimab in Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04313075|
Expanded Access Status : No longer available
First Posted : March 18, 2020
Last Update Posted : January 28, 2022
|Condition or disease||Intervention/treatment|
|Metastatic Triple-Negative Breast Carcinoma||Drug: Leronlimab|
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 Type :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population|
|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)|
- Drug: Leronlimab
Leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.Other Name: (PRO 140)