NCT05394103招募中1 期
A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 9
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit
- •Measurable disease per RECIST v 1.1
- •ECOG performance status 0,1 or 2
- •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 (Q901)
Experimental
干预措施: Q901 (Drug)
Q901 Single-Agent Expansion Cohorts
Experimental
干预措施: Q901 (Drug)
Q901 + KEYTRUDA® (pembrolizumab) Cohorts
Experimental
干预措施: Q901 (Drug)
Q901 + KEYTRUDA® (pembrolizumab) Cohorts
Experimental
干预措施: KEYTRUDA® (pembrolizumab) (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 28 days of cycle 1 (each cycle is 28 days)
次要结局
- Change in the area under curve (AUC) of Q901(Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days))
- Change in the maximum plasma concentration (Cmax) of Q901(Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days))
- Tumor response using RECIST version 1.1 throughout study(Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days))
- Change in the time of maximum plasma concentration (Tmax) of Q901(Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days))
研究者
研究点 (9)
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