EUCTR2017-002289-35-ES进行中（未招募）1 期
Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination with Pembrolizumab for First-Line Treatment of Patients with Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Seattle Genetics, Inc.0 个研究点目标入组 72 人开始时间: 2018年2月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
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
- All
入选标准
- •1. Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
- •2. Have not previously received therapy for the treatment of unresectable LA/M breast cancer.
- •3. For patients previously treated with curative intent, at least 12 months must have elapsed between the completion of such treatment (e.g., date of primary breast tumor surgery or date of last adjuvant cytotoxic therapy administration, whichever occurred last) and first documented local or distant disease recurrence.
- •4. Measureable disease per computed tomography (CT) scan as defined in RECIST v1.1: at least 1 tumor lesion =10 mm in the longest diameter, or a lymph node =15 mm in short axis measurement.
- •5. Patients =18 years of age.
- •6. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- •7. Able to provide fresh tissue for biomarker analysis from a newly obtained core or excisional biopsy of a tumor lesion.
- •8. Meet baseline laboratory data criteria.
- •9. For patients of childbearing potential as defined in Section 4.3, the following stipulations apply:
- •a. Must have a negative serum or urine pregnancy test
- •b. Must agree not to try to become pregnant from the time of enrollment until at least 6 months after the final dose of study drug.
- •10. Patient must provide written informed consent.
- •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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1. Prior treatment with SGN LIV1A.
- •2. Prior immuno-oncology therapy
- •3. Pre-existing neuropathy of Grade =2.
- •4. Radiographic evidence of central nervous system metastases.
- •5. History of leptomeningeal carcinomatosis.
- •6. Active infection requiring systemic treatment =7 days before dose of study drug.
- •7. Known to be positive for hepatitis B by surface antigen expression, active hepatitis C infection or a known history of being seropositive for HIV.
- •8. Active autoimmune disease that has required systemic treatment in past 2 years
- •9. History of interstitial lung disease.
- •10. Current pneumonitis, or history of (non-infectious, including radiation induced) pneumonitis that required steroids.
- •14. Has a diagnosis of immunodeficiency or is receiving steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- •15. Patients who are breastfeeding.
研究者
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