CTIS2023-507344-36-01进行中（未招募）1 期
A Multicenter, Open-label, Phase 2 study of Intratumoral Vidutolimod (CMP-001) in Combination with Intravenous Cemiplimab in Subjects with Selected Types of Advanced or Metastatic Cancer - CMP-001-009
Regeneron Pharmaceuticals Inc.0 个研究点目标入组 200 人开始时间: 2023年12月1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
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Histopathologically-confirmed diagnosis of cancer, as defined by the protocol, Measurable disease, as defined by RECIST v1.1 and as defined in the protocol, Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1), as defined in the protocol, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening, Other protocol defined inclusion criteria apply
排除标准
- •Received radiation therapy (or other non-systemic therapy) within 2 weeks before first dose of study treatment on W1D1. Participants should have recovered (i.e. Grade = 1 or at baseline) from radiation-related toxicities., Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment., NOTE: Other protocol defined Inclusion/Exclusion Criteria apply, Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors)., Received systemic pharmacologic doses of corticosteroids > 10 mg/day prednisone within 30 days before first dose of study treatment on W1D1, as defined in the protocol., History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody., Not fully recovered from AEs due to prior treatment (to Grade 1 or less, per Common Terminology Criteria for Adverse Events (CTCAE), with the exception of persistent vitiligo, alopecia, hypothyroidism, diabetes mellitus, and adrenal and/or pituitary insufficiency., Active pneumonitis or history of noninfectious pneumonitis that required steroids, Severe uncontrolled medical disease within 12 months of screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis, cerebrovascular accident, or implanted or continuous use of a pacemaker or defibrillator, or emphysema with FEV1 = 50% predicted., Known history of immunodeficiency., Known additional malignancy that is progressing or required active treatment within the past 3 years, as defined in the protocol.
研究者
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