A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- DLT: 21or28 days after the first administration of each subject
研究概览
简要总结
Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose for phase II clinical trials (RP2D), and preliminary efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Women aged 18 to 75 (inclusive)
- •Subjects with histologically or cytologically confirmed recurrent or metastatic solid tumors who experience disease progression after standard treatment, or who do not have a standard treatment plan or are not suitable for standard treatment.
- •ECOG score is 0 or 1
- •An expected survival of ≥3 months
- •At least one target lesion according to RECIST v1.1 criteria
- •Has a good level of organ function
- •Patients voluntarily joined the study and signed informed consent
排除标准
- •Have other malignancies within the past 5 years
- •Active central nervous system metastasis without surgery or radiotherapy
- •Presence with uncontrollable third space effusion
- •Have undergone other anti-tumor treatment within 4 weeks before the first dose
- •Has severe infection within 4 weeks before the first medication
- •Any active autoimmune disease or a history of autoimmune disease
- •A history of immune deficiency
- •Has serious cardiovascular and cerebrovascular diseases
- •Clinically significant history of lung disease
- •The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
- •Having undergone surgery on important organs within 4 weeks prior to the first use of medication
- •Used attenuated live vaccine within 28 days prior to the first use of the investigational drug
- •Presence of other serious physical or mental diseases or laboratory abnormalities
研究组 & 干预措施
Queue A
干预措施: FH-006 (Drug)
Queue B
干预措施: FH-006 (Drug)
结局指标
主要结局
DLT: 21or28 days after the first administration of each subject
时间窗: 21or28 days after the first administration of each subject
AE: from Day1 to 30 days after last dose
时间窗: from Day1 to 30 days after last dose
Incidence and severity of serious adverse events (SAE): from Day1 to 30 days after last dose
时间窗: from Day1 to 30 days after last dose
MTD or MAD： 21 or 28 days after the first dose of medication for each subject on dose escalation stage
时间窗: 21 or 28 days after the first dose of medication for each subject on dose escalation stage
RP2D：Obtain two treatment evaluation data for the last subject during the dose expansion phase
时间窗: Obtain two treatment evaluation data for the last subject during the dose expansion phase
次要结局
- Immunogenic indicators: anti-FH-006 antibody (ADA)(through study completion, an average of 2 years)