Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Condition: Advanced Triple Negative Breast Cancer (TNBC) With High TAMs
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: MCS110; carboplatin; gemcitabine
Intervention description: taken by I.V; taken by I.V; taken by I.V
Intervention MeSH terms: Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MCS110; carboplatin; gemcitabine; TNBC; TAMs

Summary:

      To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and
      gemcitabine (carbo/gem) in advanced TNBC patients
    

Eligibility criteria:

        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