Description:
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients
Completed
Phase 2
NCT ID: NCT02435680
ORG ID: CMCS110Z2201
NCI ID: 2015-000179-29
Advanced Triple Negative Breast Cancer (TNBC) With High TAMs
Drug | Synonyms | Arms |
---|---|---|
MCS110 | Arm 1: MCS110+carboplatin+gemcitabine | |
carboplatin | Arm 1: MCS110+carboplatin+gemcitabine, Arm 2: carboplatin+gemcitabine | |
gemcitabine | Arm 1: MCS110+carboplatin+gemcitabine, Arm 2: carboplatin+gemcitabine |
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and
gemcitabine (carbo/gem) in advanced TNBC patients
Name | Type | Description | Interventions |
---|---|---|---|
Arm 1: MCS110+carboplatin+gemcitabine | Experimental | MCS110+carboplatin+gemcitabine | MCS110, carboplatin, gemcitabine |
Arm 2: carboplatin+gemcitabine | Active Comparator | carboplatin+gemcitabine | carboplatin, gemcitabine |
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 (approximately 15% of TAMs or above).
- 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.
- 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) < 1.0x109/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
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Female
Progression free survival (PFS) as per RECIST v1.1 (by local investigator assessment)
Number of participants with adverse events and serioaus adverse events
Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters
Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters
Plasma concentration of carboplatin, gemcitabine and 2',2'-difluoro-deoxyuridine (dFdU)
Total Colony stimulation factor -1 (CSF-I) circulating levels, serum C-terminal telopeptide of type I collagen (CTX-I) and circulating monocytes
Tumor associated macrophage (TAM) and Tumor infiltrating lymphocyte (TIL) content in pre- and post-dose tumor biopsies
Tumor response per RECIST v1.1 (by local investigator assessment)
MCS110; carboplatin; gemcitabine; TNBC; TAMs