NCT04648254已完成1 期
A Phase 1, Multicenter, Open-label, Dose- Escalation, Safety, Pharmacodynamic, Pharmacokinetic Study of Q702 With a Cohort Expansion at the RP2D in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702
研究概览
简要总结
This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate safety and anti- tumor activity of Q702 administered orally.
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
- •Patients with histologically or cytologically confirmed advanced or metastatic solid tumors, that have progressed following standard of care therapy or for which there is no standard therapy which confers clinical benefit
- •Measurable disease per RECIST v 1.1
- •ECOG performance status 0 or 1
- •Life expectancy of at least 3 months
- •Age ≥ 18 years
- •Signed, written IRB-approved informed consent form
排除标准
- •New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months
- •Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >470 msec (females) and >450 msec (males)
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- •Active, poorly controlled autoimmune or inflammatory diseases
研究组 & 干预措施
Dose escalation (Q702)
Experimental
Participants will receive escalating doses of Q702
干预措施: Q702 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702
时间窗: 28 days of cycle 1
次要结局
- Tumor response using RECIST version 1.1 throughout study(Baseline up to approximately 2 years)
- Change in the maximum plasma concentration (Cmax) of Q702(Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22)
- Change in the time of maximum plasma concentration (Tmax) of Q702(Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22)
- Change in the area under curve (AUC) of Q702(Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22)
研究者
研究点 (4)
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