NCT05438420进行中（未招募）1 期
A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE
研究概览
简要总结
This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.
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
- •The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- •Subjects with histologically or cytologically confirmed advanced or metastatic esophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed on treatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies
- •Have measurable disease per RECIST v 1.
- •as assessed by local site investigator/radiology
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Life expectancy of at least 3 months
排除标准
- •A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment or breast-feeding women
- •Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
- •Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
- •Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
- •Has had an allogeneic tissue/solid organ transplant
研究组 & 干预措施
Dose escalation of Q702 in combination with fixed dose of pembrolizumab
Experimental
Give one week on/one week off at selected dose level
干预措施: Q702 (Drug)
Dose escalation of Q702 in combination with fixed dose of pembrolizumab
Experimental
Give one week on/one week off at selected dose level
干预措施: Pembrolizumab (Biological)
Dose expansion of Q702 in combination with fixed dose of pembrolizumab
Experimental
Give intravenously once every three week at 200 mg
干预措施: Q702 (Drug)
Dose expansion of Q702 in combination with fixed dose of pembrolizumab
Experimental
Give intravenously once every three week at 200 mg
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE
时间窗: Up to approximately 2 years (Each Cycle is 42 Days)
Tumor response using RECIST version 1.1 throughout study
时间窗: Up to approximately 2 years (Each Cycle is 42 Days)
次要结局
- Change in the area under curve (AUC) of Q702 and its primary metabolites(Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days))
研究者
研究点 (7)
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