NCT06108050招募中1 期
A Phase 1, First-in-human, Open-label, Multicenter Study of JZP898 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 177
- 试验地点
- 9
- 主要终点
- Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy
研究概览
简要总结
This Phase 1 first-in-human study will investigate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of JZP898 monotherapy as well as JZP898 in combination with pembrolizumab in adult participants with advanced or metastatic solid tumors.
详细描述
Two-part study: Part A Dose Exploration (Parts A1 and A2) and Part B Combination Expansion.
Part A Dose Exploration:
- Part A1 - a monotherapy dose exploration to determine the monotherapy recommended dose and/or maximum tolerated dose (MTD) (or highest cleared dose level) and safety profile of JZP898.
- Part A2 - a combination dose exploration of JZP898 plus pembrolizumab to determine the CombiRD (combination recommended dose for expansion).
Part B Combination Expansion:
- Part B - combination expansion using a basket design to evaluate clinical antitumor activity and safety profile of JZP898 in combination with pembrolizumab at the CombiRD identified in Part A2.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part A1 Dose Exploration: JZP898 monotherapy
Experimental
干预措施: JZP898 (Drug)
Part A2 Dose Exploration: JZP898 in combination with pembrolizumab
Experimental
干预措施: JZP898 (Drug)
Part A2 Dose Exploration: JZP898 in combination with pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
Part B Combination Expansion: JZP898 in combination with pembrolizumab
Experimental
干预措施: JZP898 (Drug)
Part B Combination Expansion: JZP898 in combination with pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy
时间窗: Up to 36 months
Incidence of TEAEs and SAEs in Monotherapy and Combination Therapy
时间窗: Up to 36 months
Incidence of dose interruptions, discontinuation, and reductions due to TEAEs in Monotherapy and Combination Therapy
时间窗: Up to 36 months
Objective Response Rate (ORR) As Assessed by the Investigator In Combination Therapy
时间窗: Up to 36 months
次要结局
- Pharmacokinetic Parameter: Maximum Concentration (Cmax) of JZP898 in Monotherapy and Combination Therapy(Up to 36 months)
- Pharmacokinetic Parameter: Time to Maximum Concentration (Tmax) of JZP898 in Monotherapy and Combination Therapy(Up to 36 months)
- Pharmacokinetic Parameter: Terminal Elimination Half-life (t½) of JZP898 in Monotherapy and Combination Therapy(Up to 36 months)
- Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of JZP898 in Monotherapy and Combination Therapy(Up to 36 months)
- Pharmacokinetic Parameter: Clearance (CL) of JZP898 in Monotherapy and Combination Therapy(Up to 36 months)
- Pharmacokinetic Parameter: Volume of Distribution (V) of JZP898 in Monotherapy and Combination Therapy(Up to 36 months)
- Pharmacokinetic Parameter: Activated IFNα-to-JZP898 Ratio in Monotherapy and Combination Therapy(Up to 36 months)
- Pharmacokinetic Parameter: Accumulation ratio for Cmax in Monotherapy and Combination Therapy(Up to 36 months)
- Pharmacokinetic Parameter: Accumulation Ratio for AUC in Monotherapy and Combination Therapy(Up to 36 months)
- ORR As Assessed by the Investigator in Monotherapy(Up to 36 months)
- Duration of Response (DoR) As Assessed by the Investigator(Up to 36 months)
- Disease Control Rate (DCR) As Assessed by the Investigator(Up to 36 months)
- Progression-free Survival (PFS) As Assessed by the Investigator(Up to 36 months)
- Overall Survival (OS)(Up to 36 months)
- Incidence of ADAs towards JZP898(Up to 36 months)
研究者
研究点 (9)
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