An Open-label, Phase 1 Study of DCC-2812 Monotherapy in Participants With Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Number of Participants with Dose-limiting Toxicities (DLTs)
研究概览
简要总结
This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced/metastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.
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
- •Have confirmed Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer
- •Able to take oral medication
- •If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements
- •Adequate organ function and electrolytes
排除标准
- •Received any prior anticancer therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-2812
- •Impaired cardiac function
- •Major surgery within 28 days of the first dose of study drug
研究组 & 干预措施
DCC-2812
Participants will receive DCC-2812 in dose escalation manner per dosing regimen depending upon evolving pharmacokinetic (PK), pharmacodynamic, and safety data.
干预措施: DCC-2812 (Drug)
结局指标
主要结局
Number of Participants with Dose-limiting Toxicities (DLTs)
时间窗: Cycle 1 (28 days)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Up to 42 months
Number of Participants With Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs
时间窗: Up to 42 months
次要结局
- PK: Area Under the Plasma Concentration-time Curve (AUC)(Predose up to 24 hours postdose (up to 42 months))
- PK: Trough Plasma Concentration (Ctrough)(Predose up to 24 hours postdose (up to 42 months))
- Radiographic Objective Response Rate (rORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Up to 42 months)
- PK: Trough Plasma Concentration (Ctrough)(Predose up to 24 hours postdose (up to 42 months))
- Radiographic Duration of Response (rDOR) per RECIST v1.1(Up to 42 months)
- PK: Maximum Observed Plasma Drug Concentration (Cmax)(Predose up to 24 hours postdose (up to 42 months))
- PK: Time to Reach Cmax (Tmax)(Predose up to 24 hours postdose (up to 42 months))
- PK: Area Under the Plasma Concentration-time Curve (AUC)(Predose up to 24 hours postdose (up to 42 months))