A Phase 1, First-in-Human Study of IK-930, an Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects with Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Safety and tolerability of IK-930
研究概览
简要总结
This is a Phase 1, first-in-human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of IK-930, an oral TEAD inhibitor, administered orally (PO) as monotherapy in subjects with advanced solid tumors with or without gene alterations in the Hippo pathway for whom there are no further treatment options known to confer clinical benefit. The study consists of two phases, an initial Dose Escalation phase followed by a Dose Expansion phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IK-930 Single Agent Dose Expansion
干预措施: IK-930 (Drug)
IK-930 Single Agent Dose Escalation
干预措施: IK-930 (Drug)
IK-930 and Osimertinib Combination Dose Escalation
干预措施: IK-930 (Drug)
IK-930 and Osimertinib Combination Dose Escalation
干预措施: Osimertinib (Drug)
结局指标
主要结局
Safety and tolerability of IK-930
时间窗: Through study completion, an average of 36 months
The frequency and severity, incidence of treatment-emergent and treatment-related adverse events using NCI-CTCAE v5.0
Occurrence of Dose Limiting Toxicity during first treatment cycle
时间窗: Approximately 1 year
RP2D and/or MTD of IK-930
时间窗: Approximately 1 year
Define the recommended phase 2 dose (RP2D) and/or MTD of IK-930
次要结局
- Antitumor activity per RECIST 1.1: Time to response (TTR) of IK-930 as a single agent(Through study completion, average of 36 months)
- Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-930 as a single agent(Through study completion, average of 36 months)
- Antitumor activity: Median progression-free survival (PFS) of IK-930 as a single agent(Through study completion, average of 36 months)
- Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-930 as a single agent(Through study completion, average of 36 months)
- Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-930 as a single agent(Through study completion, average of 36 months)
- Pharmacokinetics of IK-930: half-life (t1/2)(Approximately 1 year)
- Pharmacokinetics of IK-930: Area Under the Curve (AUC)(Approximately 1 year)
- Antitumor activity: Median overall survival (OS) of IK-930 as a single agent(Through study completion, average of 36 months)
- Pharmacokinetics of IK-930: Maximum Plasma Concentration (Cmax)(Approximately 1 year)
- Pharmacokinetics of IK-930: Minimum Plasma Concentration (Cmin)(Approximately 1 year)
研究者
Katherine Kim, MD
Scientific
Ikena Oncology Inc.