A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients With Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- The incidence of dose-limiting toxicity (DLT)
研究概览
简要总结
This is a multi-center, open-label, Phase 1 clinical study of ZG006 in the US for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. During the dose escalation stage, a standard "3+3" design will be used to assess the MTD/ recommended dose for the subsequent studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Small cell lung cancer (SCLC), who failed or intolerant to available standard treatments;
- •Tissue sample positive for DLL3 expression;
- •Life expectancy ≥ 3 months;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.
排除标准
- •Patients having received any of the following treatments:
- •Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry;
- •Systemic immunosuppressive medications, such as corticosteroid (doses > 10 mg/day prednisone or equivalent dose) within 14 days prior to the study entry;
- •Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;
- •Patients received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry;
- •A history of severe, life-threatening immune-mediated adverse events or infusion-related reactions during previous anti-tumor immunotherapy, including events that led to permanent discontinuation of treatment;
- •Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B/C, active syphilis, or active human immunodeficiency virus infection);
- •Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins;
- •A female who is pregnant or nursing;
- •Patients were deemed unsuitable for participating in the study by the investigator for any reason.
研究组 & 干预措施
Dose Escalation
干预措施: ZG006 (Drug)
结局指标
主要结局
The incidence of dose-limiting toxicity (DLT)
时间窗: Up to 28 days
An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria
Maximum Tolerated Dose (MTD) of ZG006
时间窗: Approximately 2 years
Determine the Recommended Phase 2 Dose (RP2D)
时间窗: Approximately 2 years
Number of participants with adverse events (AEs)
时间窗: Approximately 2 years
The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
Number of participants with serious adverse events (SAEs)
时间窗: Approximately 2 years
Incidence of abnormal laboratory results
时间窗: Approximately 2 years
次要结局
- Objective response rate (ORR)(Approximately 2 years)
- Duration of response (DOR)(Approximately 2 years)
- Disease control rate (DCR)(Approximately 2 years)
- Maximum plasma concentration (Cmax) of ZG006(Approximately 2 years)
- AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of ZG006(Approximately 2 years)
- Time to peak concentration (Tmax)(Approximately 2 years)
- Terminal phase half-life (t1/2) of ZG006(Approximately 2 years)
- Detection of anti-drug antibodies (ADA)(Approximately 2 years)