A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD004 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 121
- 试验地点
- 3
- 主要终点
- The dose limiting toxicity ( DLT)
研究概览
简要总结
This study is one single group of participants with advanced solid tumors. It is the first time the drug has been used in humans. There will be two parts including Dose Escalation and Dose Expansion to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FZ-AD004.
详细描述
This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FZ-AD004 in patients with advanced/metastatic solid tumors. FZ-AD004 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）during cycle 1. In addition, the maximum-tolerated dose and recommended Phase II dose for FZ-AD004 will be determined.
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
- •Patients able to give written informed consent;
- •Age ≥ 18 and ≤ 75 years old, male or female;
- •Patients have histological or cytological diagnosis with advanced solid tumors.
- •Have measurable lesions defined in RECIST v. 1.1;
- •Expected survival ≥ 12 weeks;
- •Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
- •Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.
排除标准
- •Have had other malignant tumors in the past 5 years;
- •Have CNS (central nervous system) metastasis with clinical symptoms;
- •Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
- •Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
- •Have history of psychotropic drug abuse, alcohol or drug abuse；
- •Women who are pregnant or lactating；
- •Other circumstances that is deemed not appropriate for the study.
研究组 & 干预措施
Experimental: FZ-AD004
Participants enrolled in the dose escalation part or dose expansion part
干预措施: FZ-AD004 (Drug)
结局指标
主要结局
The dose limiting toxicity ( DLT)
时间窗: 21 Days (first cycle)
To determine the dose limiting toxicities (DLTs) of FZ-AD004.
Objective Response Rate (ORR) according to RECIST 1.1
时间窗: From subject randomization up to 60 months.
To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of FZ-AD004 when administered intravenously (IV) as monotherapy at the RDEs to patients with metastatic or locally advanced unresectable tumors.
Maximum Tolerable Dose (MTD)
时间窗: 21 Days (first cycle)
To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
Adverse Events
时间窗: Screening up to study completion
To check the numbers of AEs happened during the course of trial.
次要结局
- Progression free survival(PFS) according to RECIST 1.1(From subject randomization up to 60 months.)
- Duration of Response(DOR) according to RECIST 1.1(From subject randomization up to 60 months)
- Overall Survival (OS) according to RECIST 1.1(From subject randomization up to 60 months.)
- Terminal elimination half-life (t1/2) of Total Antibody, Free DXd and FZ-AD004(Up to 17 weeks)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From subject randomization up to 60 months.)
- Maximum observed plasma concentration (Cmax) of Total Antibody, Free DXd and FZ-AD004(Up to 17 weeks)
- Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of Total Antibody, Free DXd and FZ-AD004(Up to 17 weeks)
- Time to Cmax (Tmax) of Total Antibody, Free DXd and FZ-AD004(Up to 17 weeks)