EUCTR2015-000179-29-AT进行中（未招募）1 期
A randomized phase II study of MCS110 combined with carboplatin and gemcitabine in advanced Triple Negative Breast Cancer (TNBC)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- 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-) BC 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)
- •- Bone lesions: non-measurable lytic or mixed (lytic + sclerotic) in the absence of measurable disease as defined above. Patients with only non-measurable lesions (e.g. pleural effusion, ascites) and no lytic or mixed bone lesions are not eligible.
- •Other inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •- 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 dose of study drug.
- •- 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 pre-dose:
- •- 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
- •Other exclusion criteria may apply
研究者
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