NCT07542704尚未招募1 期
A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
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
- 48
- 主要终点
- Primary Objective
研究概览
简要总结
The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are:
- What is the safe dose of KQB368 as a monotherapy?
- Does KQB368 decrease the size of the tumor?
- What happens to KQB368 in the body?
Participants will:
- Take KQB368 orally daily in 21-day cycles
- Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of a solid tumor
- •Malignancy with either a KRAS G12C or KRAS G12S mutation
- •Unresectable or metastatic disease
- •No available treatment with curative intent
- •Adequate organ function
- •Measurable disease per RECIST v1.1
- •Must be able to swallow with no GI condition that prevents absorption
排除标准
- 未提供
研究组 & 干预措施
Monotherapy Dose Escalation
Experimental
干预措施: KQB368 (Drug)
结局指标
主要结局
Primary Objective
时间窗: Up to 44 months
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 30 days after last dose of study treatment.
次要结局
- Objective response rate (ORR)(Up to 44 months)
- Overall survival (OS)(Up to 44 months)
- Duration of response (DOR)(Up to 44 months)
- Time to response (TTR)(Up to 44 months)
- Disease control rate (DCR)(Up to 44 months)
- Progression-free survival (PFS)(Up to 44 months)
- Area under the concentration-time curve (AUC)(Up to 44 months)
- Maximum plasma concentration (Cmax)(Up to 44 months)
- Time to maximum plasma concentration (tmax)(Up to 44 months)
研究者
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