Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

Inclusion Criteria:

- Adult women (≥ 18 years of age) with advanced TNBC.

- Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone
receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-)
Breast Cancer by local laboratory testing, based on last available tumor tissue.

- ER/PgR negativity to follow local guidelines

- If IHC HER2 2+, a negative FISH test is required

- A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the
central laboratory

- Patients must have:

At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or
mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets
the measurability criteria)

Exclusion Criteria:

- Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is
allowed (carboplatin, cisplatin or gemcitabine only if > 12 months has passed since
last administration).

- Therapy for underlying malignancy within 2 weeks prior to start of study treatment:

- Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)

- Radiotherapy

- Major surgery

- Patients receiving concomitant immunosuppressive agents or chronic corticosteroids
(≥10 mg of prednisone or equivalent) at the time of first study dose.

- Clinically significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
screening.

- Known history of human immunodeficiency virus or active infection with hepatitis virus
or any uncontrolled active systemic infection.

- Patients with the following laboratory values during screening and on Day 1 predose:

- Absolute Neutrophil Count (ANC) < 1.5x109/L

- Hemoglobin < 9 g/dL

- Platelets < 100x109/L

- Serum creatinine > 1.5 x ULN

- Serum total bilirubin > 1.5 x ULN

- AST/SGOT and ALT/SGPT > 3.0 x ULN