NL-OMON44080已完成2 期
A phase I, first time in human, open-label, dose escalation study to investigate the safety, pharmacokinetics, and pharmacodynamics of anti-HER3 monoclonal antibody GSK2849330 in subjects with advanced HER3-positive solid tumors - HER117158
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
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 64（—）
入选标准
- •Written informed consent obtained.
- •Males and females >=18 years of age.
- •ECOG status 0 or 1.
- •Sufficient archival tumor specimen is available for HER3 (± NRG1) analysis or willingness to provide fresh tumor sample.
- •Previously treated, unresectable stage III-IV melanoma, gastric/gastroesophageal cancer, head and neck cancer, or non small cell lung cancer, who are HER3 positive or (HN cancer or NSCLC) HER3 and NRG1 positive, see protocol page 23-25 for details.
- •Adequate contraception for females of childbearing potential (see protocol page 22-23 for details).
- •Men with a female partner of childbearing potential must agree to use effective contraception (see protocol page 23 for details).
排除标准
- •Untreated brain or meningeal metastases or spinal cord compression (see protocol page 25 for details).
- •Prior HER3- directed treatment.
- •Use of a prohibited medication (see protocol section 10.2).
- •Evidence of significant cardiovascular risk (see protocol page 26 for details).
- •Pregnancy or lactation.
研究者
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