A Phase I, Open-label, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Recombinant Humanized Anti-Trop2 mAb-Tub196 Conjugate in Patients With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors. This study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（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
Dose Escalation
干预措施: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Through study completion, an average of 1 year
The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
时间窗: A minimum of 21 days after first infusion of study drug
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
次要结局
- Maximum observed serum or plasma concentration (Cmax)(Through study completion, an average of 1 year)
- Maximum serum drug time（Tmax）(Through study completion, an average of 1 year)
- Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)(Through study completion, an average of 1 year)
- Anti-drug antibodies (ADA)(Through study completion, an average of 1 year)
- Overall Survival (OS)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
- Volume of distribution at steady state (Vss)(Through study completion, an average of 1 year)
- Objective Response Rate (ORR)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
- Duration of response (DOR)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
- Progression Free Survival (PFS)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
- Terminal phase elimination half life (t½)(Through study completion, an average of 1 year)
- Clearance (CL)(Through study completion, an average of 1 year)
- Levels of Trop2 (trophoblast antigen 2) expression in tumor tissue(Through study completion, an average of 1 year)