jRCT2031240563招募中不适用
A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors (J5Q-OX-JRDA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA
- •Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer
- •Have measurable disease per RECIST 1.1
- •Have an ECOG performance status of<=1
- •Must not be pregnant and/or planning to breastfeed during the trial or within 180 days of the last dose of trial intervention
- •Must be able to swallow tablets
- •Participants with asymptomatic or treated CNS disease may be eligible
排除标准
- •Have known active CNS metastases and/or carcinomatous meningitis
- •Have any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 1 at the time of starting trial treatment, except for alopecia, peripheral neuropathy and ongoing endocrinopathies controlled on appropriate replacement therapy
- •Have significant cardiovascular disease defined as unstable angina or acute coronary syndrome, history of myocardial infarction, known left ventricular ejection fraction or heart failure, uncontrolled or symptomatic arrhythmias.
- •Have known active hepatitis B virus (HBV), hepatitis C virus (HCV) and untreated HIV infection
- •Have other active malignancy unless in remission with life expectancy greater than 2 years.
- •Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- •Have history of non-infectious pneumonitis/interstitial lung disease that received steroids or has current clinically significant pneumonitis/interstitial lung disease
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Up to approximately 5 years
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
次要结局
未报告次要终点
研究者
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