NL-OMON51317撤回不适用
A Phase 1/2, open-label, multicenter, dose escalation and dose expansion study of SAR442720 in combination with other agents in participants with advanced malignancies - TCD16210
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 5
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 99（—）
入选标准
- •- Participants must be >= 18 years of age
- •- Histologically proven diagnosis of advanced solid tumors
- •- Participants must have one or more of the following molecular aberrations:
- •KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations
- •- Participants must have following molecular aberration (Part 3A and 3B): -
- •KRAS G12C mutation
- •- At least 1 measurable disease per RECIST 1.1 criteria.
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •- Woman of childbearing potential must agree to follow contraceptive guidance
- •- Capable of giving signed informed consent
排除标准
- •- Predicted life expectancy <3 months.
- •- Primary central nervous system (CNS) tumors.
- •- Symptomatic or impending cord compression. Stable CNS disease is allowed.
- •- History of cerebrovascular stroke or transient ischemic attack within
- •previous 6 months.
- •- Prior solid organ or hematologic transplant.
- •- History or current retinal pigment epithelial detachment (RPED), central
- •serous retinopathy, retinal vascular occlusion (RVO), neovascular macular
- •degeneration
- •- Any clinically significant cardiac disease
- •- Active, known or suspected autoimmune disease
- •- History of or current interstitial lung disease or pneumonitis
- •- Receipt of a live-virus vaccination within 28 days, viral vaccine that do not
- •contain live virus within 7 days of planned treatment start. Seasonal flu
- •vaccines that do not contain live virus are permitted.
- •- Known infection with human immunodeficiency virus (HIV), known uncontrolled
- •hepatitis B infection, active tuberculosis, or severe infection requiring
- •parenteral antibiotic treatment.
- •- Inadequate hematologic, hepatic and renal function
- •- Known second malignancy
- •- Impairment of gastrointestinal function
- •- Any unstable or clinically significant concurrent medical condition that
- •would, in the opinion of the investigator, jeopardize the safety of a
- •participant, impact their expected survival through the end of the study
- •participation, and/or impact their ability to comply with the protocol.
- •- History of severe allergic reaction to any of the study intervention
研究者
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