NCT04316689已完成1 期
Open-label, Phase 1 Study of S-488210/S-488211 to Evaluate the Safety and Tolerability in Patients With Unresectable Recurrent and/or Metastatic Solid Tumor
Shionogi2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年7月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The primary objective is to evaluate the safety and tolerability of S-588210 (S-488210+S-488211) in patients with unresectable recurrent and/or metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unresectable recurrent and/or metastatic solid tumor of lung, esophageal, head and neck, mesothelioma, or bladder cancer (including urothelial cancer of renal pelvis, ureters, and urethra), who have progressed after conventional systemic therapies or have exhausted or are intolerant to existing treatment options.
- •Human leukocyte antigen (HLA)-A*02:01-positive patients.
- •Patients who are male or female aged ≥18 years at the time of informed consent.
- •Patients with the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at enrollment.
- •Patients who have a lymphocyte count accounting for 15% or higher of the total white blood cell count within 28 days before enrollment.
- •Patients who provide a personally signed and dated informed consent document for participation in the study.
- •Patients with expected life-span of at least 3 months from the time of enrollment.
排除标准
- •Patients who are expected to require any of the following therapies between enrollment and completion of the Observation Period.
- •Anti-malignant tumor drug
- •Systemic corticosteroid (except for corticosteroid defined as the equivalent of prednisone ≤ 10 mg/day orally)
- •Systemic immunosuppressant drug
- •Radiotherapy (except for restricted radiotherapy for pain relief of bone metastasis) for the cancer(s)
- •Surgical therapy for the cancer(s)
- •Hyperthermia for the cancer(s)
- •Traditional Chinese herbal medicine with anti-tumor or immunosuppressant effect
- •Other investigational products
- •Patients who have severe concurrent hepatic impairment, renal impairment, heart disease, hematological disease, respiratory disease, or metabolic disease, with the exception of any symptoms and/or signs associated with cancer(s).
- •Patients who have known human immunodeficiency virus infection.
- •Patients with uncontrolled systemic or active infection.
- •Patients who had any diseases with the risk of sudden death within 12 months before enrollment.
- •Patients with a history or evidence of autoimmune diseases and/or immunodeficiencies.
- •Female patients who are pregnant, breastfeeding, or have a positive pregnancy test at the predose examinations.
- •Patients who are considered ineligible for this study by the investigator or subinvestigator due to any reasons, including inability to understand and follow the requirements of the study.
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to 16 weeks
Adverse events will be classified by system organ class and preferred term using Medical Dictionary for Regulatory Activities (MedDRA).
次要结局
- Cytotoxic T Lymphocyte (CTL) Induction Rate(Baseline and Weeks 8 and 12)
研究者
研究点 (2)
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