A Multicenter, Open-label, Dose-escalation, Phase Ia/Ib Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CKD-512 Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Part A: Maximum tolerated dose (MTD) or Optimal biologically effective dose (OBED)
研究概览
简要总结
The purpose of this first-in-human (FiH) study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of CKD-512 given alone and in combination with pembrolizumab in subjects with advanced or metastatic solid tumors who have failed all standard available therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced or metastatic solid tumors.
- •Progressive disease after or intolerance to standard therapy and no other effective therapeutic options available.
- •Measurable disease as defined in Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Suitable venous access for the study-required blood sampling, including PK and PD sampling.
- •Adequate clinical laboratory values and other measures
排除标准
- •Active disease involvement of the central nervous system.
- •Any serious or life-threatening medical condition unrelated to cancer, psychiatric illness, drug or alcohol abuse, that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- •Systemic anticancer treatment within the protocol-specified period prior to the first dose.
- •History of any immune-related toxicity that lead to permanent discontinuation of prior anticancer therapy
- •Radiation therapy on a limited area is allowed until 4 weeks prior to the first dose of study drug, provided that the radiated lesion is clinically stable.
- •Prior treatment with investigational agents ≤21 days before the first dose of study drug(s).
研究组 & 干预措施
Part A: Monotherapy
Dose Level(DL) 1 to DL 6
干预措施: CKD-512 (Drug)
Part B: Combination therapy
DL N to DL N+2, combination with Pembrolizumab
干预措施: CKD-512 (Drug)
Part B: Combination therapy
DL N to DL N+2, combination with Pembrolizumab
干预措施: Pembrolizumab (Combination Product)
结局指标
主要结局
Part A: Maximum tolerated dose (MTD) or Optimal biologically effective dose (OBED)
时间窗: Up to 2 years
Number and proportion of subjects who experience at least 1 DLT based on incidence, nature, and severity of TEAEs and SAEs graded according to NCI-CTCAE version 5.0 as well as on changes from baseline assessments.
Part B: Recommended dose for expansion (RDE)
时间窗: Up to 2 years
Number and proportion of subjects who experience at least 1 DLT based on incidence, nature, and severity of TEAEs and SAEs graded according to NCI-CTCAE version 5.0 as well as on changes from baseline assessments.
次要结局
- Safety and tolerability(Up to 2 years)
- Maximum Observed Plasma Concentration (Cmax)(Up to 2 years)
- Cmax at steady state (Cmax_ss)(Up to 2 years)
- Area Under the Curve to the last measurable concentration (AUClast)(Up to 2 years)
- Area Under the Curve over the dosing interval tau (AUCtau)(Up to 2 years)
- Overall Response Rate (ORR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Progression-Free Survival (PFS)(Up to 2 years)