A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors
概览
- 阶段
- 1 期
- 干预措施
- FZ-AD005
- 疾病 / 适应症
- Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)
- 发起方
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- 入组人数
- 162
- 试验地点
- 3
- 主要终点
- Adverse Events (AEs）
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.
研究者
入排标准
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 ( especially SCLC or LCNEC);
- •Willingness to provide tumor tissue for testing ;
- •Have measurable lesions defined in RECIST v. 1.1;
- •Expected survival ≥ 3 months;
- •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
- •Patients who have had previous treatment with any anti-DLL3 antibody；
- •Have had other malignant tumors in the past 5 years;
- •Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
- •Have active CNS (central nervous system) metastasis；
- •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;
- •Patients have psychiatric history;
- •Female patients who are breastfeeding or pregnant;
- •Other reasons that researchers believe are inappropriate to participate in this study.
研究组 & 干预措施
FZ-AD005
干预措施: FZ-AD005
结局指标
主要结局
Adverse Events (AEs）
时间窗: Screening up to study completion, assessed up to 60 months
To check the numbers of AEs happened during the course of trial.
Objective Response Rate (ORR)
时间窗: Up to 60 months
To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of FZ-AD005 according to RECIST 1.1
The dose limiting toxicity ( DLT)
时间窗: 21 Days (first cycle)
To determine the dose limiting toxicities (DLTs) of FZ-AD005
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.
次要结局
- Terminal elimination half-life (t1/2)(Up to 18 weeks)
- Maximum observed plasma concentration (Cmax)(Up to 18 weeks)
- Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity(Up to 18 weeks)
- Progression free survival(PFS)(Up to 60 months)
- Duration of Response(DOR)(Up to 60 months)
- Overall Survival (OS)(Up to 60 months)
- Anti Drug Antibody (ADA)(Up to 36 months)
- Time to peak (Tmax)(Up to 18 weeks)
- Time to Cmax (Tmax)(Up to 18 weeks)