NCT03973151已完成1 期
A Phase I/II, Single Arm, Dose Escalation and Cohort Expansion Study to Evaluate Safety, Preliminary Efficacy of HL-085 in Patients With NRAS Mutant Advanced Melanoma
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
- 42
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a phase I/II, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with NRAS mutant advanced melanoma .
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma according to AJCC (Version 7, 2010).
- •Subjects must have NRAS mutation in melanoma.
- •Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
- •ECOG performance status of 0-
- •Life expectancy ≥ 3 months.
- •Ability to take the medicine orally.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Prior therapy with a MEK-inhibitor
- •Patients with known hypersensitivity to study drug ingredients or their analogues.
- •Active central nervous system (CNS) lesion.
- •ECG QTcB≥480msec in screening, or history of congenital long QT syndrome.
- •Subjects with bleeding symptoms at Grade 3 (NCI-CTCAE v4.03) within 4 weeks prior to starting study treatment.
- •Uncontrolled concomitant diseases or infectious diseases.
- •Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
- •History of HIV,HCV,HBV infection.
- •Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.
- •Serum HCG test is positive.
- •Other conditions that influence the results and increase the risk of study.
研究组 & 干预措施
HL-085
Experimental
HL-085 will be administered as BID with specified dose.
干预措施: HL-085 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: DLTs within the first cycle of therapy (up to 35 days)
The dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity (DLT)
Number of participants with adverse events
时间窗: Duration of the study, estimated to be approximately 24 months.
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 during the study period
次要结局
- Half-life (T1/2)(Duration of the study, estimated to be approximately 24 months.)
- Objective Response Rate (ORR) as measure of efficacy(Duration of the study, estimated to be approximately 24 months.)
- Area under the plasma concentration versus time curve (AUC)(Duration of the study, estimated to be approximately 24 months)
- Peak Plasma Concentration (Cmax)(Duration of the study, estimated to be approximately 24 months)
- Time to maximum observed plasma drug concentration (Tmax)(Duration of the study, estimated to be approximately 24 months.)
研究者
研究点 (2)
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