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
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 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.
Diet and Nutrition,
Chronic Shoulder Pain,
Adverse Effects, Drugs,
Breast Cancer - HER2 Positive,
Near-Sighted Corrective Surgery,
Peripheral Arterial Occlusive Disease,
Triple Negative Breast Cancer,
Triple Negative Breast Neoplasms,
Recurrent Respiratory Papillomatosis,
Razor Bumps (Pseudofolliculitis Barbae),
Metastatic Triple-Negative Breast Cancer
350 mg leronlimab,
525 mg leronlimab,
700 mg leronlimab,
AUC 5 Carboplatin,
Maximum Tolerated Dose (MTD) of leronlimab
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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