NCT06963398尚未招募1 期
A Phase 1 Study, Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10529 Monotherapy in KRAS G12D Patients With Advanced Solid Tumors
Jiangsu Hansoh Pharmaceutical Co., Ltd.0 个研究点目标入组 520 人开始时间: 2025年5月15日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 520
- 主要终点
- The maximum tolerated dose (MTD) or maximum applicable dose (MAD)
研究概览
简要总结
HS-10529 is an oral, highly selective, small molecular inhibitor of KRAS G12D. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10529 in KRAS G12D patients with advanced solid tumors.
详细描述
This is a phase 1, first-in-human, study of HS-10529, consisting of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10529 in KRAS G12D patients with advanced solid tumors and evaluate the preliminary efficacy of HS-10529.
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
- •At least age of 18 years at screening.
- •Patients of advanced solid tumor，who have progressed on or intolerant to standard therapy.
- •With measurable lesion according to RECIST 1.
- •Agree to provide fresh or archival tumor tissue.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
排除标准
- •Previous or current treatment with KRAS G12D inhibitors.
- •Uncontrolled pleural, ascites or pericardial effusion.
- •Known and untreated, or active central nervous system metastases.
- •History of other primary malignant tumors.
- •Serious, uncontrolled, or active comorbidities.
- •Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.
研究组 & 干预措施
HS-10529
Experimental
干预措施: HS-10529 (Drug)
结局指标
主要结局
The maximum tolerated dose (MTD) or maximum applicable dose (MAD)
时间窗: up to 24 months
次要结局
- Incidence and severity of treatment-emergent adverse events(up to 24 months)
- Plasma concentration of HS-10529(up to 36 months)
研究者
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