A Phase 2, Multicenter, Study Evaluating the Efficacy, Safety, Tolerability, Pharmacokinetics of KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GI Stromal Tumor in 1st Line Setting
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 17
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.
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
- •All Participants:
- •Unresectable or metastatic disease
- •Tissue confirmation of GIST
- •Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V).
- •Measurable disease per RECIST v1.
- •Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago.
- •Adequate organ function and performance status
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Unable to swallow or GI condition that prevents absorption.
- •Other active malignancies within the last 2 years.
- •History of hypersensitivity to any component of KQB198 or imatinib.
研究组 & 干预措施
KQB198 in Combination with Imatinib
干预措施: KQB198 (Drug)
KQB198 in Combination with Imatinib
干预措施: Imatinib (Gleevec) (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 30 months
Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria in Gastrointestinal Stromal Tumors (GIST). Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.
次要结局
- Duration of response (DOR)(30 months)
- Disease control rate (DCR)(30 months)
- Time to response (TTR)(30 months)
- Progression-free survival (PFS)(Up to 30 months)
- Overall survival (OS)(Up to 30 months)
- Number of patients who experience treatment-emergent adverse advents, serious adverse events, and dose-limiting toxicities (Part 1)(From enrollment to the end of treatment)
- Area under the curve (AUC)(Up to 30 months)
- Maximum plasma concentration (Cmax)(Up to 30 months)
- Time to maximum plasma concentration (Tmax)(Up to 30 months)