EUCTR2017-002846-61-GB进行中（未招募）1 期
A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab (SAR650984) in Combination with REGN2810, or Isatuximab alone, in Patients with Advanced Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 168
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
- •- Patients must have a known diagnosis of either metastatic castration-resistant prostate cancer (mCRPC) or non-small cell lung cancer (NSCLC) with evidence of measurable disease.
- •- Failure of, inability to, or refusal to receive standard of care.
- •- =18 years of age.
- •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 126
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •- Prior exposure to isatuximab or participation in clinical studies with isatuximab.
- •- For patients with mCRPC, prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway.
- •- Evidence of other immune related disease /conditions.
- •- History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.
- •- Has received a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- •- Prior solid organ or hematologic transplant.
- •- Eastern Cooperative Oncology Group performance status (PS) =2.
- •- Poor bone marrow reserve.
- •- Poor organ function.
研究者
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