EUCTR2017-002289-35-DE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1月5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
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 6 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 adequate tissue obtained recently from a tumor lesion for biomarker analysis. Core needle or excisional biopsy is preferred. If neither is possible, discuss with sponsor whether biopsy obtained via alternative methods may be appropriate.
- •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 if they are able to. If a patient is unable to provide written informed consent, then written informed consent can be provided by a legally authorized representative (LAR) in accordance with local legal requirements.
- •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 carcinomatous meningitis or active central nervous system (CNS) metastases. Patients are eligible if CNS metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. In addition, patients must be completely off corticosteroids.
- •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.
- •11.Has received prior radiotherapy within 2 weeks of start of study treatment. Except, if prior radiation therapy is >2 weeks, and participants have recovered from all radiation-related toxicities, do not require corticosteroids, and have not had radiation pneumonitis.
- •12. Active autoimmune disease that has required systemic treatment in past 2 years
- •13. History of interstitial lung disease.
- •14. Current pneumonitis, or history of (non-infectious, including radiation induced) pneumonitis that required steroids.
- •15. 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.
- •16. Patients who are breastfeeding.
研究者
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