NCT07618377招募中1 期
A Phase 1 Study to Evaluate the Safety of DCC-2618 in Patients With Unresectable, Metastatic, or Recurrent Gastrointestinal Stromal Tumor (GIST) Who Are Refractory or Intolerant to at Least 3 Prior Therapies
Ono Pharmaceutical Co., Ltd.2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年7月7日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
研究概览
简要总结
To evaluate the safety of DCC-2618 in patients with unresectable, metastatic, or recurrent gastrointestinal stromal tumor (GIST) who have received three or more prior therapies
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
- •Participants with a histologically confirmed diagnosis of GIST.
- •Participants who are refractory or intolerant to treatment with at least imatinib, sunitinib, and regorafenib.
- •Participants with at least one measurable lesion per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) within 28 days prior to the first administration of the investigational product.
- •Participants with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
排除标准
- •Participants with a concomitant or prior history of severe hypersensitivity reactions to other tyrosine kinase inhibitors.
- •Participants with uncontrolled diabetes mellitus.
- •Participants with a systemic infection requiring treatment.
研究组 & 干预措施
DCC-2618
Experimental
干预措施: DCC-2618 (Drug)
研究者
研究点 (2)
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