A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety and Efficacy of TWP-101 in Patients With Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Incidence of dose-limiting toxicity (DLT)
研究概览
简要总结
This is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety and efficacy of TWP-101 in patients with advanced solid tumor. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or cytologically confirmed advanced solid tumor that failed, couldn't tolerate or refused standard treatments;
- •ECOG score 0 or 1;
- •At least 1 measurable lesion according to RECIST 1.1
排除标准
- •Known hypersensitivity to any ingredient of TWP-101;
- •Receiving any anti-cancer drugs within 4 weeks;
- •History of serious systemic diseases;
- •History of serious autoimmune diseases;
- •Pregnancy or lactating women.
研究组 & 干预措施
Dose Escalation Cohort
Three dose levels of TWP-101 will be tested by a conventional 3 + 3 study design.
干预措施: TWP-101 (Drug)
Dose Expansion Cohort
Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
干预措施: TWP-101 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLT)
时间窗: From the first dose of study drug up to 4 weeks
Incidence of adverse events and serious adverse event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)) and irAE.
时间窗: From enrollment until 90 days after the last dose
次要结局
- Progression free survival (PFS).(From first dose to disease progression or end of study, an average of 2 years)
- Time to maximum plasma concentration (Tmax) of TWP-101.(From first dose until 90 days after the last dose)
- Objective Response Rate (ORR) by RECIST Version 1.1(From first dose to disease progression or end of study, an average of 2 years)
- Duration of Response (DOR)(From first dose to disease progression, an average of 2 years)
- Disease control rate (DCR).(From first dose to disease progression or end of study, an average of 2 years)
- Maximum measured plasma concentration (Cmax) of TWP-101.(From first dose until 90 days after the last dose)
- Half-life (T1/2) of TWP-101.(From first dose until 90 days after the last dose)
- Immunogenicity profile of TWP-101.(From first dose until 90 days after the last dose)