A Phase 1/2a, Open-Label, Safety, Pharmacokinetic, And Preliminary Efficacy Study Of Oral ATRN-119 In Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 7
- 主要终点
- Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of ATRN-119 through the performance of a Phase 1/2a, open-label, safety, PK, and preliminary efficacy study of oral ATRN-119 in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DNA damage response (DDR) mutations documented in the past medical record or confirmed during the screening period.
- •Measurable disease defined by RECIST 1.
- •Life expectancy ≥ 3 months.
- •Subject must be capable of oral administration of study medication.
排除标准
- •Patient has had a cytotoxic chemotherapy, immunotherapy, radiotherapy or other targeted therapies within 4 weeks.
- •Surgical procedure performed within 7 days prior to first scheduled dose of ATRN-
- •Concomitant treatment with strong inhibitors or inducers of CYP3A4 and CYP2D
- •Known human immunodeficiency virus infection (HIV).
- •Subjects with active viral or bacterial infections and/or receiving systemic antibiotics or anti-viral medications.
- •Current or past diagnosis of leukemia within the past 5 years.
- •Prior radiotherapy at the target lesion unless there is evidence of disease progression.
- •Known CNS metastases or clinical evidence of CNS involvement that is not stable for previous 1 month by radiology documentation (magnetic resonance imaging [MRI] brain).
- •History of non-malignant gastronintestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months.
- •Patient has uncontrolled hypertension at time of enrollment.
- •Complete left bundle branch block (LBBB), bifascicular block (right bundle branch block [RBBB] with either left anterior hemiblock or left posterior hemiblock).
- •Any clinically significant ST segment and/or T-wave abnormalities.
- •Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication.
研究组 & 干预措施
50mg ATRN-119
Once daily oral administration.
干预措施: ATRN-119 (Drug)
100mg ATRN-119
Once daily oral administration.
干预措施: ATRN-119 (Drug)
1100mg ATRN-119
Once daily oral administration
干预措施: ATRN-119 (Drug)
1300mg ATRN-119
Once daily oral administration
干预措施: ATRN-119 (Drug)
200mg ATRN-119
Once daily oral administration.
干预措施: ATRN-119 (Drug)
400mg ATRN-119
Twice daily oral administration.
干预措施: ATRN-119 (Drug)
650mg ATRN-119
Twice daily oral administration.
干预措施: ATRN-119 (Drug)
800 mg ATRN-119
Once daily oral administration
干预措施: ATRN-119 (Drug)
350mg ATRN-119
Once daily oral administration.
干预措施: ATRN-119 (Drug)
1500mg ATRN-119
Once daily oral administration
干预措施: ATRN-119 (Drug)
750mg ATRN-119
Twice daily oral administration.
干预措施: ATRN-119 (Drug)
550mg ATRN-119
Once or twice daily oral administration
干预措施: ATRN-119 (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics
时间窗: Day 1 to Day 28
Treatment-emergent AEs (TEAEs) will be collected and Clinical Laboratory Evaluations will be performed
次要结局
未报告次要终点