A First-in-Human, Phase 1 Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 9
- 主要终点
- Incidence of Dose Limiting Toxicities of ERX-315
研究概览
简要总结
This is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies.
详细描述
The goal of this open-label, dose escalation and cohort expansion Phase 1 clinical trial is to determine the safety, tolerability and pharmacokinetics of ERX-315 in patients with advanced solid tumors, who have progressed on prior approved systemic therapies. Participants will receive ERX-315 as an intravenous (IV) injection twice a week, over 21-day cycles.
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
- •Patients must be at least 18 years of age at the time of signing the informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Patients must have histologically or cytologically confirmed solid tumor, primarily including but not limited to breast, ovarian, pancreatic, endometrial and hepatocellular carcinoma, that is advanced unresectable and/or metastatic disease for whom standard therapies do not exist or are no longer effective
- •Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Adequate baseline organ function and hematologic function
- •Life expectancy >3 months
排除标准
- •Systemic anti cancer therapy within 4 weeks of first dose of study drug
- •Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
- •Uncontrolled intercurrent illnesses
- •Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.
研究组 & 干预措施
ERX-315
Active investigational therapy
干预措施: ERX-315 (Drug)
结局指标
主要结局
Incidence of Dose Limiting Toxicities of ERX-315
时间窗: 21 days
First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315
时间窗: 84 days
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Incidence of Adverse Events as a measure of safety and tolerability of ERX-315
时间窗: 84 days
Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.
Determination of the recommended phase 2 dose
时间窗: 84 days
To determine the recommended phase 2 dose(s) for additional evaluation of ERX-315 in clinical trials for participants with advanced solid tumors
次要结局
- Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).(21 days)
- Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)(21 days)
- Antitumor activity of ERX-315 based on Objective response rate (ORR)(84 days)
- Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)(84 days)
- Antitumor activity of ERX-315 based on Duration of response (DOR)(84 days)
- Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)(21 days)
- Antitumor activity of ERX-315 based on Progression-free survival (PFS)(84 days)