Neoplasms

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Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

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Antineoplastic Agents

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Antibodies

Antibodies, Monoclonal

Carboplatin

Immunoglobulins

Leronlimab

HIV Antibodies

Anti-HIV Agents

Anti-Retroviral Agents

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Immunologic Factors

Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks

Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks

Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks

MTD PRO 140 SC + AUC 5 Carboplatin in 30 subjects

leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.

350 mg leronlimab

525 mg leronlimab

700 mg leronlimab

Carboplatin is an anticancer drug chemotherapy drug.

AUC 5 Carboplatin

The decision on the MTD will be made following the results obtained from Phase I studies

Maximum Tolerated Dose (MTD) of leronlimab

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).

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC	NCT03838367	Triple Negative...	350 mg leronlim... 525 mg leronlim... 700 mg leronlim... AUC 5 Carboplat... Maximum Tolerat...	18 Years -	CytoDyn, Inc.
Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC	NCT03838367	Triple Negative...	350 mg leronlim... 525 mg leronlim... 700 mg leronlim... AUC 5 Carboplat... Maximum Tolerat...	18 Years -	CytoDyn, Inc.

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