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

• Status: Completed
• Trial end date: 2020-03-23
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Carboplatin; Gemcitabine

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