A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 15
- 主要终点
- Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131
研究概览
简要总结
A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or metastatic non-small cell lung cancer (NSCLC).
详细描述
Phase 1 Dose Escalation: To evaluate the overall safety profile, efficacy of TPX-0131 in pretreated subjects with ALK+ advanced or metastatic NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 (or as required by local regulation).
- •Histological or cytological confirmation of advanced/metastatic ALK+ NSCLC.
- •Pretreated with up to three prior lines of an ALK TKI treatment, including at least one prior line of a second or third-generation ALK TKI (alectinib, brigatinib, ensartinib, or lorlatinib) in Phase
- •ECOG performance status ≤
- •Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria).
- •Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.
- •Adequate organ function.
排除标准
- •Major surgery within four weeks of the start of TPX-0131 treatment.
- •Clinically significant cardiovascular disease
- •Any of the following cardiac criteria:
- •Mean resting corrected QT interval (QTc) > 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events
- •Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
- •Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
- •Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
- •Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
- •Subjects with current or anticipated need for drugs that are sensitive CYP2C9 substrates with narrow therapeutic indices.
研究组 & 干预措施
TPX-0131
The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131.
干预措施: TPX-0131 (Drug)
结局指标
主要结局
Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131
时间窗: Within 28 days of the first TPX-0131 dose for each patient
Evaluate the safety and tolerability of TPX-0131
Define the Recommended Phase 2 Dose
时间窗: Approximately 24 months
Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131
次要结局
- Adverse events (AEs)(Approximately 34 months)