NCT04169711已完成1 期
A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ARO-HIF2 injection (also referred to as ARO-HIF2) and to determine the recommended Phase 2 dose in the treatment of patients with advanced clear cell renal cell carcinoma (ccRCC).
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
- •Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
- •Willing to provide written informed consent and to comply with study requirements
- •Histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma that has progressed during or after at least two prior therapeutic regimens which must include vascular endothelial growth factor (VEGF)-targeted therapy and checkpoint inhibitor therapy or that has otherwise failed such therapies, is measurable disease per RECIST 1.1 criteria, is biopsy accessible
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •Estimated life expectancy of longer than 3 months
- •Adequate organ function at screening
排除标准
- •History of untreated brain metastasis or leptomeningeal disease or spinal cord compression
- •Failure to recover from reversible effects of prior anti-cancer therapy
- •Has received systemic therapy or radiation therapy within 2 weeks prior to first dose
- •History of solid organ or stem cell transplantation
- •Current use of anti-VEGF or mammalian target of rapamycin (mTOR) agents, or chronic immunosuppressive therapy
- •Any prior use of hypoxia inducible factor 2 (HIF2) inhibitors within 6 months prior to first dose
- •Current use of immune checkpoint inhibitors
- •Use of an investigational agent or device within 2 weeks prior to dosing, or current participation in an investigational study
- •Known HIV, hepatitis B or hepatitis C
- •History of other clinically meaningful disease
- •Major surgery within 4 weeks of Screening
- •Active malignancy requiring therapy other than ccRCC within 3 years of study entry
- •Note: Other eligibility criteria may apply per protocol.
研究组 & 干预措施
ARO-HIF2
Experimental
干预措施: ARO-HIF2 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
时间窗: Up to 2 years from first dose
次要结局
- PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to 4 Hours (AUC0-4)(Up to Week 2: predose and up to 48 hours postdose)
- PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)(Up to Week 2: predose and up to 48 hours postdose)
- PK of ARO-HIF2: Terminal Elimination Half-Life (t1/2)(Up to Week 2: predose and up to 48 hours postdose)
- Time to Response(Baseline until disease progression, up to 2 years)
- Progression Free Survival(up to 2 years)
- PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Measurable Concentration at a Time=t, Using a Specified Trapezoidal Rule (AUC0-t)(Up to Week 2: predose and up to 48 hours postdose)
- Overall Response Rate(Baseline until disease progression, up to 2 years)
- Duration of Response(Baseline until disease progression, up to 2 years)
- Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax)(Up to Week 2: predose and up to 48 hours postdose)
- PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax)(Up to Week 2: predose and up to 48 hours postdose)
- Systemic Clearance Derived From Intravenous Dose/Area Under the Plasma Concentration Versus Time Curve (CL)(Up to Week 2: predose and up to 48 hours postdose)
- Amount of Drug Excreted in the Urine Over One Dosing Interval Through 4 Hours Post- Dose (Ae, 0-4)(Up to Week 2: predose and up to 48 hours postdose)
- Fraction Excreted (or Equivalently the Percent of Dose Excreted) in the Urine, Calculated by 100 X (Ae, 0-4 h/Dose)(Up to Week 2: predose and up to 48 hours postdose)
- Overall Survival(up to 2 years)
- PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUCinf)(Up to Week 2: predose and up to 48 hours postdose)
- Renal Clearance Calculated by Ae, 0-4 h/AUC0-4h (CLR)(Up to Week 2: predose and up to 48 hours postdose)
研究者
研究点 (5)
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