An Open Label, Multicenter Study of DPTX3186 to Evaluate Safety, Tolerability, and Pharmacokinetics in Subjects With Known Wnt Pathway Activated Solid Tumors Where No Other Treatments Exist
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of treatment emergent adverse events and serious adverse events.
研究概览
简要总结
This is a first-in human clinical study of DPTX3186 in subjects with Wnt-pathway activated solid tumors where no other treatments exist. The study will evaluate safety, pharmacokinetics, and initial activity of DPTX3186, as well as explore pharmacodynamic parameters to identify potential biomarkers of efficacy
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 or cytologically confirmed solid tumor and tumor types known to be Wnt-pathway activated (such as colorectal cancer, gastric cancer, lung cancer, and triple negative breast cancer) and no other approved treatment options available.
- •At least one measurable target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI.
- •ECOG performance status of 0 or
- •Physiological conditions that may prevent absorption of an oral medication including but not limited to colostomy and ileostomy.
- •Age ≥18 years (or ≥ age of majority per local regulation)
- •Life expectancy ≥3 months
- •Willing and able to comply with protocol requirements
排除标准
- •Symptomatic or uncontrolled brain metastasis requiring concurrent treatment,
- •Another known malignancy that is progressing or requires active treatment within the last 2 years (except basal cell carcinoma, in situ cervical cancer, etc.).
- •Inadequate organ function
- •Known hypersensitivity to study drug or excipients
研究组 & 干预措施
Dose Escalation
干预措施: DPTX3186 (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events and serious adverse events.
时间窗: Up to 36 Months
1. Outcome Measure: Incidence of Treatment Emergent Adverse-Events Measure Description: Number of subjects with treatment-emergent adverse events (TEAEs) Time Frame: up to 36 months 2. Outcome Measure: Incidence of Serious Adverse Events Measure Description: Number of subjects with serious adverse events (SAEs) Time Frame: up to 36 months
次要结局
未报告次要终点