NCT07809607尚未招募1 期
An Open-Label, Multicenter, Phase I Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of YF087 in Patients With Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Number of subjects participants with adverse events
研究概览
简要总结
This is an open-label, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of YF087 in subjects with Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) advanced solid tumors.
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
- •Subjects with locally advanced (unresectable) or metastatic solid tumors;
- •dMMR/MSI-H status demonstrated in tumor tissue, blood, or other samples containing cancer cells or DNA;
- •Subjects must have experienced disease progression after the most recent therapy for advanced disease (prior therapy must include at least one PD-1/PD-L1 inhibitor treatment).
- •Presence of at least 1 measurable lesion that can be measured by CT or MRI based on RECIST V1.1 criteria;
排除标准
- •Prior treatment with a WRN inhibitor such as HRO760, RO7589831, GSK4418959 and NDI-219216;
- •Prior to the first dose of study intervention, receipt of any anticancer treatment (including chemotherapy, targeted therapy, immunotherapy, etc.) or any other investigational medicinal product within 14 days or 3 half-lives (whichever is shorter);
- •Subjects with unstable or symptomatic or progressive central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis and/or brainstem metastases and/or spinal cord compression;
- •Subjects with clinically significant cardiovascular and cerebrovascular disease
- •Subjects with concomitant medical conditions that the investigator believes may increase the risk of toxicity, such as serious cardiovascular, respiratory or neurological diseases;
- •Use of, or planned use of, any of the following medications that has not been discontinued for at least 14 days or 5 half-lives (whichever is shorter) before the first study drug administration:
- •Strong CYP3A4 inducers or inhibitors;
- •Drugs known to prolong the QT interval.
- •Pregnant or lactating females;
研究组 & 干预措施
YF087
Experimental
干预措施: YF087 (Drug)
结局指标
主要结局
Number of subjects participants with adverse events
时间窗: From enrollment to 30 days after last dose
Number of subjects participants with adverse events
Subject incidence of Dose-limiting toxicities (DLT)
时间窗: From enrollment to Cycle 1 Day 21
Objective response rate (ORR)
时间窗: From enrollment to the end of treatment, about 1 year
次要结局
- Progression free survival (PFS)(From enrollment to the end of treatment, about 1 year)
- Duration of Response (DOR)(From enrollment to the end of treatment, about 1 year)
- Change from baseline in QT/QTc interval(On Cycle 0 Day 1 and Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days))
- Disease control rate (DCR)-assessed by IRC and investigators(From enrollment to the end of treatment, about 1 year)
- Primary PK parameters: area under the concentration-time curve from the time of dosing to time t (AUC0-t)(From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days))
- Primary PK parameters: area under the concentration-time curve from time 0 to infinity (AUC0-∞)(From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days))
- Primary PK parameters: Mean residence time (MRT)(From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days))
- Primary PK parameters: maximum concentration (Cmax)(From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days))
- Primary PK parameters: Time to maximum concentration (Tmax)(From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days))
- Primary PK parameters: t1/2(From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days))
- Primary PK parameters: Apparent Volume of Distribution (Vz/F)(From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days))
研究者
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