A Multi-center, Open-label, Phase I/Ib Study to Assess the Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, a Poly (ADP-ribose) Polymerase (PARP) Inhibitor, in Patients With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 6
- 主要终点
- Maximum tolerated dose (MTD) of RP12146 in patients with locally advanced or metastatic solid tumors
研究概览
简要总结
An open-label, two-part Phase I/Ib study of RP12146 in adult patients with locally advanced or metastatic solid tumors. The first part (Part 1) is a Phase I dose-escalation, 3+3 design, open-label, MTD determination study and will enroll patients who have tumors known to harbour DNA repair deficiencies. The second part (Part 2) is a Phase Ib, dose-expansion at the MTD (or optimal dose) and will enroll patients with a confirmed deleterious HRR mutation in their tumor as identified by a central genomics testing laboratory.
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
- 未提供
排除标准
- •Patients with HER2 positive breast cancer
- •Patients receiving anticancer therapy
- •Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
- •Prior treatment with a PARP inhibitor
- •Major surgery within 4 weeks of starting study treatment or any patient who has not recovered from the effects of major surgery.
- •Patient with symptomatic uncontrolled brain metastasis.
- •Pregnancy and lactation
- •Patients with uncontrolled disease
研究组 & 干预措施
RP12146
RP12146 will be administered orally daily (QD or BID)
干预措施: RP12146 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of RP12146 in patients with locally advanced or metastatic solid tumors
时间窗: 28 days
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0
时间窗: 2 years
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients will be monitored for adverse events and both related and as well as non-related adverse events will be captured during the study. All adverse events (irrespective of causality) will be reported.
次要结局
- Overall response rate (ORR)(2 years)
- Cmax(Day 1 to Day 28)
- AUC(Day 1 to Day 28)
- Clinical benefit rate (CBR)(2 years)
- Progression free survival (PFS)(2 years)
- Tmax(Day 1 to Day 28)