A Phase Ib/II Study of Atamparib in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- RP2D and MTD
研究概览
简要总结
This is a multi-part, open-label, non-randomized phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of atamparib, an investigational agent, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) adenocarcinoma. The study comprises dose escalation (phase Ib) and expansion (phase II).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be ≥18 years of age.
- •Histologically confirmed diagnosis of unresectable advanced or metastatic NSCLC adenocarcinoma.
- •Documented KRAS mutation status at study entry.
- •Have received at least one line of standard therapy and experienced radiographic tumor progression to the last administered treatment and have failed institutional standards of care.
- •Have measurable tumor lesions
- •Adequate organ functions
排除标准
- •Non-adenocarcinoma histology of NSCLC. Patients whose tumors have a mixed histology are ineligible.
- •Wtih oncogenic driver mutation other than KRAS for which an approved therapy is available but not adequately treated.
- •Known active GI disease that would impact the absorption
- •Clinically significant cardiac disease
- •Requiring the administration of strong inhibitors or inducers of CYP3A4, P-gp or BCRP.
- •Symptomatic, or untreated CNS lesions.
研究组 & 干预措施
monotherapy escalation
Atamparib
干预措施: atamparib escalation levels (Drug)
Expansion Arm d
Atamparib
干预措施: atamparib RP2D (Drug)
Espansion Arm a
Atamparib
干预措施: atamparib RP2D (Drug)
Expansion Arm b
Atamparib
干预措施: atamparib RP2D (Drug)
Expansion Arm c
Atamparib
干预措施: atamparib RP2D (Drug)
结局指标
主要结局
RP2D and MTD
时间窗: 28 days after the last dose
First cycle DLTs and all other available study data
Type, incidence and severity of adverse event
时间窗: until 28 days after the last dose
Safety and tolerability profile assessed by the CTCAE v6.0
次要结局
未报告次要终点