EUCTR2022-000137-17-DE进行中（未招募）1 期
A Phase 1/2 Dose Escalation and Dose Expansion Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BioAtla
- 入组人数
- 134
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
- 性别
- All
入选标准
- •Patients must:
- •- Have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC or melanoma;
- •- Age = 18 Year;
- •- Adequate renal function
- •- Adequate liver function;
- •- Adequate hematological function;
- •- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •- Life expectancy of at least three months
- •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 41
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 93
排除标准
- •- Clinically significant cardiac disease;
- •- Known non-controlled central nervous system (CNS) metastasis;
- •- Prior therapy with a conjugated or unconjugated auristatin derivative / vinca-binding site targeting payload;
- •- A history of = Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
- •- Major surgery within 4 weeks before first BA3011 administration;
- •- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
- •- Women who are pregnant or breast feeding
研究者
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