A Multi-center, Phase I, Open Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Incidence of adverse events/serious adverse event related with TWP-102 injection
研究概览
简要总结
This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 confirmed advanced malignancies that failed, or not suitable for standard treatments;
- •At least 1 measurable lesion.
- •ECOG score 0 or 1;
- •Life expectancy of ≥ 3 months;
排除标准
- •Known hypersensitivity to any ingredient of TWP-102;
- •Receiving any anti-cancer drugs within 4 weeks;
- •History of serious systemic diseases;
- •History of serious autoimmune diseases;
- •Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade > 1 severity that is related to prior anti-cancer therapy. (except alopecia)
- •Pregnancy or lactating women.
研究组 & 干预措施
Dose Escalation Cohort
Four dose levels of TWP-102 injection will be tested by BOIN study design.
干预措施: TWP-102 injection (Drug)
Dose Expansion Cohort
Once the effective doses have been determined, two expansion cohorts will be opened to evaluate the efficacy and safety in one or two tumors.
干预措施: TWP-102 injection (Drug)
结局指标
主要结局
Incidence of adverse events/serious adverse event related with TWP-102 injection
时间窗: From enrollment until 90 days after the last dose
Dose-limiting toxicity (DLT)
时间窗: From the first dose of study drug up to 3 weeks
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-102 injection.(From first dose until 90 days after the last dose)
- Maximum measured plasma concentration (Cmax) of TWP-102 injection.(From first dose until 90 days after the last dose)
- Half-life (T1/2) of TWP-102 injection.(From first dose until 90 days after the last dose)
- Immunogenicity profile of TWP-102 injection.(From first dose until 90 days after the last dose)
- Objective Response Rate (ORR)(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 or end of study, an average of 2 years)
- Disease control rate (DCR)(From first dose to disease progression or end of study, an average of 2 years)