An Open-Label, Phase 1/1b, Single-Agent Study of RXDX-105 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 14
- 主要终点
- Phase 1: Dose Limiting Toxicities
研究概览
简要总结
This is a first-in-human, multicenter, open-label study consisting of 2 phases. Phase 1 is a dose escalation study of RXDX-105 (formerly known as CEP-32496) in patients with advanced solid tumors aimed at defining the recommended Phase 2 dose (RP2D) and schedule for administration. Phase 1b is a dose expansion in approximately 90 patients with advanced solid tumors with specific histologies and/or molecular alterations of interest. Patients in Phase 1b will be treated at the RP2D determined in Phase 1.
详细描述
The primary objective of Phase 1 is to determine the recommended Phase 2 dose (RP2D) of RXDX-105. The primary objective of Phase 1b is to further assess the safety profile and tolerability of RXDX-105 at the RP2D The secondary objective is to evaluate the antitumor activity of RXDX-105 at the RP2D, as assessed by objective response rate (ORR) (complete response [CR] or partial response [PR]) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in patients with advanced solid tumors with RET or BRAF mutations or rearrangements.
The RP2D has been determined and Phase 1 portion of the study is now closed to new patient enrollment.
Phase 1 b is open and enrolling patients with solid tumors harboring a RET rearrangement or mutation, or a BRAF rearrangement or mutation. Additionally, patients with Squamous NSCLC and lung adenocarcinomas with other alterations than RET or BRAF such as KRAS mutations, etc. will also be enrolled. Approximately 90 patients will be enrolled in Phase 1b.
Each phase of this study will consist of a 28-day screening period. Patients will be treated in 28-day treatment cycles until documented radiographic progression, unacceptable toxicity, withdrawal of consent, or protocol specified parameters to stop treatment. Patients in Phase 1 and 1b will be followed for 6 months after the last dose of study treatment.
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
- 未提供
研究组 & 干预措施
RXDX-105
干预措施: RXDX-105 (Drug)
结局指标
主要结局
Phase 1: Dose Limiting Toxicities
时间窗: Approximately 12 months
From signing of the informed consent up to approximately 12 months
Phase 1: Occurrence of Adverse Events
时间窗: Approximately 12 months
From signing of the informed consent up to approximately 12 months
Phase 1b: Occurrence of Adverse Events
时间窗: Approximately 12 months
To further assess the safety profile and tolerability of RXDX-105 at the RP2D
次要结局
- Phase 1: Terminal elimination half-life (t1/2)(Day 1 to Day 16)
- Phase 1: Area under the plasma drug concentration versus time curve from time 0 to the last measureable drug concentration (AUC0-t)(Day 1 to Day 16)
- Phase 1: Terminal elimination rate constant (λz)(Day 1 to Day 16)
- Phase 1: Apparent clearance of study drug from plasma (CL/F)(Day 1 to Day 16)
- Phase 1b: Objective Response Rate(Approximately 12 months)
- Phase 1b: Duration of Objective Response(Approximately 12 months)
- Phase 1b: Clinical Benefit Rate(Approximately 12 months)
- Phase 1: Maximum observed plasma drug concentration (Cmax)(Day 1 to Day 16)
- Phase 1: Time of maximum observed plasma drug concentration (tmax)(Day 1 to Day 16)
- Phase 1: Area under the plasma drug concentration versus time curve from time 0 to infinity (AUC0-∞)(Day 1 to Day 16)
- Phase 1: Area under the plasma drug concentration versus time curve from time 0 to 24 hours after study drug administration (AUC0-24)(Day 1 to Day 16)