A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 10
- 主要终点
- Number of Participants who experience a Dose-Limiting Toxicity (DLT)
研究概览
简要总结
This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/metastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer (mCRPC) and pancreatic cancer with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes.
Condition or disease Intervention/treatment Phase Advanced Solid Tumors Drug: EIK1004 (IMP1707) Phase 1/Phase 2
详细描述
This study will evaluate the safety, tolerability and preliminary efficacy of EIK1004 (IMP1707) as monotherapy in patients with recurrent, advanced/metastatic solid tumors. The study consists of 2 parts: Dose escalation and dose optimization.
In dose escalation (Part1), the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor.
In dose optimization (Part 2), the study will further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of EIK1004 (IMP1707)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy.
- •Previously treated CNS metastases
排除标准
- •Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of EIK1004 (IMP1707)
- •Have received prior PARP1 selective inhibitors
- •Mean resting QTcF > 470 ms or QTcF < 340 ms
- •Infections
- •An active hepatitis B/C infection
- •Any known predisposition to bleeding
- •Unable to swallow oral medications OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair the bioavailability
- •CNS Exclusion Criteria
- •Any untreated brain lesions > 2.0 cm in size.
- •Ongoing use of systemic corticosteroids for control of symptoms of CNS metastases < 7 days prior to the first dose of study treatment or requirement for > 10 mg prednisone/day.
- •Any brain lesion requiring immediate local therapy, including (but not limited to) a lesion in an anatomic site where an increase in size or possible treatment-related edema may pose risk to the participant (eg, brain stem lesions).
- •Known, symptomatic leptomeningeal disease.
- •Have poorly controlled seizures.
研究组 & 干预措施
Part 1
EIK1004 (IMP1707) monotherapy; oral tablet(s) daily (except for the single-dose period). Participants will receive escalating doses of EIK1004 (IMP1707) until progressive disease or discontinuation.
干预措施: EIK1004-001 (IMP1707-001) (Drug)
结局指标
主要结局
Number of Participants who experience a Dose-Limiting Toxicity (DLT)
时间窗: (Timeframe: up to 28 days)
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). The number of participants who experience a DLT will be reported.
Number of participants with adverse events, treatment emergent adverse events or serious adverse events
时间窗: (Time Frame: 1 month post last dose of EIK1004 (IMP1707)
Number of participants reporting adverse events or serious adverse events which include any abnormal clinical events, laboratory assessments outside of normal clinical range, abnormal vital signs observed, and any abnormal ECG parameters
次要结局
- Pharmacokinetic parameters of EIK1004 (IMP1707)(Time Frame: Through study completion, up to 3 years)
- Objective Response (OR)(Through study completion, up to 3 years)