Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
研究概览
简要总结
This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer.
The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally.
- •Eastern cooperative oncology group (ECOG) performance status ≤
- •Measurable disease as per RECIST v1.1
- •Availability of tumor sample:
排除标准
- •Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Impaired cardiac function or any clinically significant cardiac disease Patients with abnormal laboratory values during screening and on day 1 of pre-dose Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
CT-707
ALK-positive non-small cell lung cancer resistant to Crizotinib treatment
干预措施: CT-707 (Drug)
结局指标
主要结局
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
时间窗: 28 days
Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-707 in ALK-positive non-small cell lung cancer (NSCLC) patients. Cycle = 28 days
Frequency of adverse events/serious adverse events
时间窗: Up to 24 months
Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms
次要结局
- Overall Response Rate (ORR) - Phase I(Up to 24 month)
- Progression free survival (PFS) per RECIST v1.1 - Phase I(Up to 24 months)
- Duration of response (DOR)(Up to 24 months)