A First-in-Human Open-label, Phase I Dose Escalation and Expansion Cohort Study of EOS301984 as Monotherapy and in Combination With Other,Anticancer Treatments in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 6
- 主要终点
- To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors
研究概览
简要总结
APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.
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 1A dose escalation
EOS301984 dose escalation as monotherapy
干预措施: EOS301984 (Drug)
Part 1B dose escalation
EOS301984 in combination with other cancer therapies
干预措施: EOS301984 (Drug)
Part 1B dose escalation
EOS301984 in combination with other cancer therapies
干预措施: Anti-PD-1 monoclonal antibody (Drug)
结局指标
主要结局
To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors
时间窗: From first study treatment administration to last participant last follow-up (Up to 4 years)
Incidence and severity of AEs in patients receiving EEOS301984
时间窗: From first study treatment administration to last participant last follow-up (Up to 4 years)
次要结局
- Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(From first study treatment administration to last participant last follow-up (Up to 4 years))
- Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level(From first dose up to 21 days repeated cycles)
- Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level(From first dose up to 21 days repeated cycles)
- Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors.(From first study treatment administration to last participant last follow-up (Up to 4 years))