Phase 2
Completed N=50
Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Advanced Triple Negative Breast Cancer (TNBC) With High TAMs
Source: ClinicalTrials.gov NCT02435680 ↗
Enrolled (actual)
50
Serious AEs
40.2%
Results posted
Jun 2021
Primary outcomePrimary: Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment) — 5.6; 5.5 months
Summary
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment) |
5.6; 5.5 | — |
| SECONDARY Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtau |
1430; 2960; 1840; 3240 | — |
| SECONDARY Free MCS110 : Derived Pharmacokinetics (PK) Parameters: Cmax |
186; 281; 240; 319 | — |
| SECONDARY Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU) |
12400; 12500; 11200; 9550; 10000; 11600 | — |
| SECONDARY AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU) |
24500; 21400; 21800; 18300; 17500; 20500 | — |
| SECONDARY Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels |
110; 115; 4930; 4350; 21600; 19500 | — |
| SECONDARY Serum C-terminal Telopeptide of Type I Collagen (CTX-I) |
79.4; 85.0; 72.5; 80.2; 65.6; 69.4 | — |
| SECONDARY Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) |
8; 6; 1; 0; 19; 7 | — |
| SECONDARY Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) Duration of Response |
9.6; 5 | — |
| SECONDARY Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose Interruption |
3; 5; 6; 9 | — |
| SECONDARY MCS110 Dose Intensity |
1; 4; 8; 3; 7; 5 | — |
| SECONDARY Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies. |
42.1; 43.5; 102; 99.0 | — |
| SECONDARY Circulating Monocytes Cells in Blood |
43.5; 54.8; 86.6; 12.2; 9.1; 89.7 | — |
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) 1.5 x ULN
- Serum total bilirubin > 1.5 x ULN
- AST/SGOT and ALT/SGPT > 3.0 x ULN
Data sourced from ClinicalTrials.gov (NCT02435680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.