A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 13
- 主要终点
- Phase 1-Part 1A (Dose Finding)- Assessment of Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.
详细描述
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of REC-1245 for the treatment of participants with unresectable locally advanced or metastatic solid tumors. Participants will receive treatment with REC-1245 for up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed / refractory lymphoma
- •Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or have been considered ineligible for standard therapy.
- •Eastern cooperative oncology group (ECOG) performance status ≤1; for adolescent participants, Lansky Performance Status Scale or Karnofsky Performance Status Scale score of ≥
- •Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 / Lugano criteria and documented by computed tomography (CT) and / or magnetic resonance imaging (MRI)
排除标准
- •Received treatment with another RBM39 degrader
- •Clinically significant gastrointestinal (GI) or GI malabsorption
研究组 & 干预措施
Phase 1b Cohort A
干预措施: REC-1245 (Drug)
Phase 1b Cohort B
干预措施: REC-1245 (Drug)
Phase 2 Cohort 1 Dose #1
干预措施: REC-1245 (Drug)
Phase 2 Cohort 1 Dose #2
干预措施: REC-1245 (Drug)
Phase 2 Cohort 2 Dose #1
干预措施: REC-1245 (Drug)
Phase 2 Cohort 2 Dose #2
干预措施: REC-1245 (Drug)
Phase 1b Cohort C
干预措施: REC-1245 (Drug)
Phase 1b Cohort D
干预措施: REC-1245 (Drug)
Phase 1a
Dose Finding
干预措施: REC-1245 (Drug)
结局指标
主要结局
Phase 1-Part 1A (Dose Finding)- Assessment of Dose Limiting Toxicities (DLTs)
时间窗: Initiation of study drug through 4 weeks
To characterize the incidence of DLTs
Phase 1 and 2 -Treatment-emergent Adverse Events
时间窗: Initiation of study drug through 30 days after the last dose (up to approximately 24 months)
To characterize the incidence of treatment emergent adverse events
Phase 2- Objective Response Rate (ORR)
时间窗: Initiation from study drug until disease progression (up to approximately 24 months)
To assess tumor response
次要结局
- Phase 1- ORR(Initiation from study drug until disease progression (up to approximately 24 months))
- Phase 1 - Time to Reach Maximum Plasma Concentration (Tmax)(Initiation of study drug through Week 9)
- Phase 1 - Plasma Concentration Before the Next Dose (Ctrough)(Initiation of study drug through Week 9)
- Phase 1 - Area Under Plasma Concentration-time Curve (AUC)(Initiation of study drug through Week 9)
- Phase 1 and 2- Disease Control Rate (DCR)(Initiation from study drug until disease progression as applicable (up to approximately 24 months))
- Phase 1 and 2 - Duration of Stable Disease (SD)(Initiation from study drug until disease progression as applicable (up to approximately 24 months))
- Phase 1 and 2 - Time to Response (TTR)(Initiation from study drug until disease progression as applicable (up to approximately 24 months))
- Phase 1 and 2 - Progression Free Survival (PFS)(Initiation from study drug until disease progression as applicable (up to approximately 24 months))
- Phase 1 and 2 - Duration of Response (DOR)(Initiation from study drug until disease progression as applicable (up to approximately 24 months))
- Phase 1 and 2 - Overall Survival (OS)(Initiation from study drug until disease progression as applicable (up to approximately 24 months))
- Phase 1 - Maximum Plasma Concentration (Cmax)(Initiation of study drug through Week 9)