A Phase 1 Study to Evaluate the Safety and Efficacy Investigate the Immunogenicity and Pharmacokinetic Characteristics of QLF3108 Injection in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- DLTs of QLF3108
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in patients with advanced solid tumor.
详细描述
This is a single-arm, open-label, Phase 1, dose escalation and Pharmacokinetics (PK) expansion study of QLF3108 in subjects with advanced solid tumor, to determine the dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and establish a recommended Phase 2 dose (RP2D) of QLF3108. The purpose of this study is to describe the safety and tolerability, assess pharmacokinetics parameters and immunogenicity, and assess the anti-tumor activity of QLF3108 in subjects with advanced solid tumor.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The volunteer has fully given informed consent to the study and voluntarily signed the informed consent form prior to trial.
- •≥18 years old and body weight ≥40 kg; Female or male.
- •Histologically or cytologically documented advanced solid tumor;
- •Failed to standard therapy or intolerance, or lack standard therapy advanced solid tumors.
- •Eastern Cooperative Oncology Group（ECOG） performance status of 0 or
- •Life expectancy of at least 12 weeks.
- •Adequate hematologic and end organ function.
- •Female subjects who are not pregnant or not breastfeeding. A negative blood pregnancy test for females of childbearing potential within 7 days prior to first dosing.
- •Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study.
排除标准
- •Patients that have previously received cancer therapy within 4 weeks prior to the first dose of the investigational drug.
- •Patient has received other investigational drug or other clinical trial treatment within 4 weeks prior to the first dose of the investigational drug.
- •Active autoimmune disease that has required systemic treatment within 2 years prior to this study.
- •A live vaccine or live attenuated vaccine was administered within 30 days prior to the first dose of the investigational drug.
- •Patients with Adverse Events(AEs) from previous treatment that have not recovered to ≤1(CTCAE 5.0）; or are unstable status.
- •Severe concomitant medical condition for bowel obstruction, or implanted colon stent during screening period.
- •Patients with a history of HIV positive or other immunodeficiency. Or patients with the history of organ transplant or allogeneic bone marrow (excluding corneal transplantation).
- •Patients with a history of psychiatric disorders, or epilepsy or dementia, drug or alcohol abuse, may impact patient completion of the study.
- •Patients may interfere with the interpretation of study results as determined by the investigator, or are unable to participate in the whole study, or deemed unsuitable by the investigator.
研究组 & 干预措施
Dose-Escalation Stage and PK-Expansion Stage
Dose-Escalation Stage：Participants will be assigned sequentially to escalating doses of QLF3108, up to the maximum tolerated dose (MTD).
PK-Expansion Stage：1-4 recommended expansion dose will be proposed for the PK-expansion stage of the trial.
干预措施: QLF3108 (Drug)
结局指标
主要结局
DLTs of QLF3108
时间窗: Approximately 24 months
dose-limiting toxicity
RP2D of QLF3108
时间窗: Approximately 24 months
a recommended Phase 2 dose
MTD(s) of QLF3108
时间窗: Approximately 24 months
the maximum tolerated dose
次要结局
- Tl/2 of QLF3108(Approximately 24 month)
- Cmax of QLF3108(Approximately 24 month)
- Tmax of QLF3108(Approximately 24 month)
- The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0(Approximately 24 month)
- The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0(Approximately 24 month)
- Area under the plasma concentration-time curve (AUC) of QLF3108(Approximately 24 month)
- Overall Response Rate (ORR)(Approximately 24 months)
- Duration of Response (DOR)(Approximately 24 months)
- Progression-free survival (PFS)(Approximately 24 months)
- Overall survival time (OS)(Approximately 24 months)