A Phase 1 Dose Escalation Study of SDX-7320 to Assess the Safety and Tolerability in Patients With Advanced Refractory or Late-Stage Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose
研究概览
简要总结
This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.
详细描述
This is a Phase 1 dose escalation study to assess the safety and tolerability of subcutaneously administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.
Once the MTD has been determined up to 12 patients will be treated at this dose level, to further characterize treatment emergent adverse events (TEAEs).
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have at least one site of radiographically measurable disease.
- •Eastern Cooperative Oncology Group (ECOG) status ≤
- •Adequate renal and liver functions.
- •Life expectancy ≥3 months.
排除标准
- •Patients that have undergone organ transplant surgery.
- •The patient has a known history of Hepatitis A, B, or C and is on active anti-viral therapy.
- •History of gastric bypass surgery or banding procedure.
- •Uncontrolled or refractory hypertension: systolic >180 or diastolic >110, or hypotension: systolic <90 or diastolic <50 despite medical treatment.
- •Participation in any other trial of an investigational agent within 30 days prior to first dose of study drug.
- •The resting 12-lead electrocardiogram obtained during screening shows QTc (Fridericia correction) ≥470 ms or has a congenital prolonged QT syndrome.
研究组 & 干预措施
SDX-7320
Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined.
干预措施: SDX-7320 (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose
时间窗: Up to 30 days after last subject enrolled
次要结局
- Anti-tumor activity(From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks)